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Mail-delivered arthritis self-management tool kitA randomized trial and longitudinal followup.

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Arthritis & Rheumatism (Arthritis Care & Research)
Vol. 61, No. 7, July 15, 2009, pp 867– 875
DOI 10.1002/art.24587
© 2009, American College of Rheumatology
ORIGINAL ARTICLE
Mail-Delivered Arthritis Self-Management Tool
Kit: A Randomized Trial and Longitudinal
Followup
JEAN GOEPPINGER,1 KATE R. LORIG,2 PHILIP L. RITTER,2 SONAL MUTATKAR,1 FRANK VILLA,2
ZIYA GIZLICE1
AND
Objective. To determine the effectiveness of an intervention Tool Kit of arthritis self-management materials to be sent
once through the mail, and to describe the populations reached.
Methods. Spanish speakers (n ⴝ 335), non-Hispanic English-speaking African Americans (n ⴝ 156), and other nonHispanic English speakers (n ⴝ 404) were recruited separately and randomized within each of the 3 ethnic/racial
categories to immediately receive the intervention Tool Kit (n ⴝ 458) or to a 4-month wait-list control status (n ⴝ 463).
At the end of 4 months, controls were sent the Tool Kit. All subjects were followed in a longitudinal study for 9 months.
Self-administered measures included health status, health behavior, arthritis self-efficacy, medical care utilization, and
demographic variables. Using analyses of covariance and t-tests, analyses were conducted for all participants and for
Spanish- and English-language groups.
Results. At 4 months, comparing all intervention subjects with randomized wait-list controls, there were significant (P <
0.01) benefits in all outcomes except medical care utilization and self-rated health. The results were maintained at 9
months compared with baseline. On average, the Tool Kit reached persons ages 50 –56 years with 12–15 years of
schooling. There were few differences between English- and Spanish-language participants in either the effectiveness or
reach variables.
Conclusion. A mailed Arthritis Self-Management Tool Kit proved effective in improving health status, health behavior,
and self-efficacy variables for up to 9 months. It also reached younger persons in both English- and Spanish-language
groups and Spanish speakers with higher education levels than previous studies of the small-group Arthritis SelfManagement Program.
INTRODUCTION
Arthritis is the most common cause of disability, a major
reason for outpatient visits, and one of the most prevalent
chronic conditions (1,2). Among older people, arthritis
frequently complicates other chronic conditions (3). Over
ClinicalTrials.gov identifier: NCT00449474.
Supported by Cooperative Agreement S3493 from the
Centers for Disease Control and Prevention.
1
Jean Goeppinger, PhD, RN, Sonal Mutatkar, MHA, Ziya
Gizlice, PhD: University of North Carolina, Chapel Hill;
2
Kate R. Lorig, RN, DrPH, Philip L. Ritter, PhD, Frank Villa,
MPH: Stanford University, Palo Alto, California.
Dr. Lorig receives royalties (less than $10,000) from Bull
Publications and De Cobo Press for materials in the Arthritis
Tool Kit.
Address correspondence to Jean Goeppinger, PhD, RN,
University of North Carolina at Chapel Hill, Carrington
Hall, Chapel Hill, NC 27599-7460. E-mail: jgoeppin@email.
unc.edu.
Submitted for publication December 18, 2008; accepted in
revised form March 16, 2009.
the past 25 years, consistent evidence has been accumulated of the effectiveness of arthritis self-management education packaged in small-group, home study, computer,
and Internet modalities (4 –10).
Consequently, numerous national bodies have recommended arthritis self-management education to complement medical care (11–14). Despite these recommendations, arthritis self-management education has reached
only a limited number of people (Boutaugh M: personal
communication). Many Arthritis Foundation chapters
have had difficulty disseminating arthritis self-management education programs. Supplementing the 6-lesson
small-group format of the classic Arthritis Self-Management Program (ASMP) with one-time mail delivery may
foster dissemination by lessening problems in recruiting,
training, and retaining group leaders; identifying accessible and acceptable meeting places; and scheduling programs. One study noted that many vulnerable populations
have not been included in study samples (15). Another
study reported that less than 50% of a closed eligible
population participated, even when Internet and small867
868
group programs were offered repeatedly over many years
(16). Other recent studies have questioned clinical significance (17,18). No studies were found where arthritis
self-management education was delivered in a one-time
mailing.
This study sought to replicate effectiveness findings,
establish clinical significance, and extend the reach of
arthritis self-management education. Here we report on
the 4-month randomized trial and 9-month longitudinal
study of a mailed Arthritis Self-Management Tool Kit.
MATERIALS AND METHODS
The Arthritis Program of the Centers for Disease Control
and Prevention (CDC) sponsored the development, dissemination, and evaluation of the Tool Kit. The maildelivered Tool Kit was designed for persons with multiple
arthritic conditions, English- or Spanish-language skills,
and a range of literacy levels. Participants could self-tailor
the materials.
Intervention description. The Arthritis Self-Management Tool Kit was packaged in a plastic envelope and
contains 1) a “Self Test” to help participants determine
how arthritis affects their lives and self-tailor the use of the
Tool Kit, including items related to pain, fatigue, physical
limitations, and health worries; participants score this test
themselves and are directed to specific parts of the Tool
Kit based on their scores; 2) information sheets: Working
with Your Doctor and the Health Care System, Exercise,
Medications, Healthy Eating, Fatigue and Pain Management, Finding Community Resources, and Dealing with
One’s Emotions; 3) information sheets on key process components of the ASMP: Action Planning, Problem Solving,
Deciding What to Try, and Individualizing an Exercise
Program; 4) The Arthritis Helpbook or Cómo Convivir Con
Sur Artritis (19,20); 5) audio relaxation and exercise compact discs (CDs); and 6) an audio CD of all material printed
on the information sheets.
Intervention formatting. In an effort to reach audiences
diverse in language and literacy levels, the information
sheets were written in English, translated to Spanish, and
then translated back to English. They were recorded by
persons of both sexes, different ages, and varying types of
arthritis and racial/ethnic groups. This ensured modeling
of essential content and processes by persons similar to the
participants. The English version used African American,
Asian American, and European American voices, and the
Spanish version used Hispanic American, Mexican, and
Central American voices.
The Spanish audio exercise CD was translated into English, and the English audio relaxation CD was translated
into Spanish. The Arthritis Helpbook and Cómo Convivir
Con Sur Artritis were originally written in English and
Spanish, respectively.
The Arthritis Helpbook and Cómo Convivir Con Sur
Artritis were written at sixth- to seventh-grade levels, and
the information sheets were written at eighth- to ninthgrade levels. The CDs are designed for individuals who
Goeppinger et al
choose to listen to, rather than read, the materials. All
materials are culturally appropriate presentations, not linguistically precise translations of the language in which
they were created.
Study design. The Tool Kit was mailed to intervention
participants at the beginning of the study and to control
participants when they had completed their 4-month questionnaire. Longitudinal data were collected from all participants 9 months after receiving the Tool Kit.
Coordinating centers. Stanford University coordinated
the Spanish-language arm of the study and the University
of North Carolina (UNC) at Chapel Hill coordinated the
English arm of the study. The Tool Kit intervention and
study protocols were developed collaboratively and used
at both universities.
Sample composition. The study was designed to include 900 participants, randomized equally into treatment
and control groups. We aimed to include 300 Spanishspeaking participants and 600 English-language participants, including 300 non-Hispanic African Americans and
300 non-Hispanic whites. This would allow enough power
at a 0.80 level to detect effect size differences of 0.3 at the
0.05 significance level (2-tailed test) in the total sample
and within each of the 3 ethnic groups, given an expected
attrition of 20%. The effect size (0.3) was the level considered to reflect clinically significant changes in previous
outcome studies (21). Although 900 participants were enrolled, the number of African American participants was
less than intended, so the English-speaking subset could
not be further segmented by ethnicity.
Recruitment. We employed a phased targeted recruitment strategy in an effort to reach both Spanish and English speakers, including African Americans. Nineteen
CDC-sponsored state health department arthritis units
were recruited in phase 1. They received a recruitment
packet containing general recruitment tips and specific
suggestions for each population, as well as press releases,
public service announcements, and sample flyers in both
English and Spanish. Units had access to a dedicated Web
site where all recruitment materials could be downloaded.
They were invited to participate in monthly conference
calls and were encouraged to contact UNC for technical
assistance; UNC also e-mailed monthly recruitment updates. This 3-month effort resulted in the recruitment of 85
study participants, 60 (71%) of whom were non-Hispanic
whites.
Because few participants were recruited, researchers assumed responsibility for recruiting in phase 2. We advertised with flyers and in lay health magazines, gave face-toface talks, made guest appearances on radio and television
talk shows, sent e-mail and Web announcements, and
encouraged professional referrals. An additional 836 participants were recruited and enrolled. The most effective
recruiting methods were group-specific and included the
use of public service announcements on national Spanishlanguage television, participation in African American ra-
Mailed Arthritis Self-Management Tool Kit
dio talk shows, and personal contact (non-Hispanic African Americans). Advertisements in lay health magazines
and announcements on arthritis Web sites resulted in the
greatest number of non-Hispanic white participants.
Potential participants called English- or Spanish-language toll-free telephone numbers, where a staff member
explained the study and determined their eligibility. The
study protocol and consent forms were approved by the
Institutional Review Boards for human subjects at Stanford and UNC.
Eligibility criteria. There were 4 eligibility criteria: age
ⱖ18 years; self-reported physician diagnosis of osteoarthritis, rheumatoid arthritis, or fibromyalgia, or the presence of chronic joint symptoms as determined by CDC
criteria; no prior participation in the small-group ASMP or
Chronic Disease Self-Management Program; and the ability
to complete research questionnaires.
Data collection procedures. Outcome data were collected via a self-report questionnaire in the language and
by the method preferred by the participant, either by mail
or telephone. Previous studies have determined that
equivalent data are collected by both data collection methods (22). Baseline data were collected prior to randomization. Three attempts were made by telephone at varying
times, to gather missing or incomplete data.
Outcome measures. There were 7 health status measures. Visual numeric scales used to measure pain and
fatigue were developed at Stanford and were found to
correlate highly with visual analog scales with a higher
completion rate (23). The Health Distress Scale was
adapted from the Medical Outcomes Study and focuses on
the distress associated with health problems (24). Selfrated global health comes from the National Health Survey
and has been found to be predictive of future health status
(25). The Activities Limitation Scale measures the impact
of disease on role activities such as recreation and chores
(26). The 8-item version of the Health Assessment Questionnaire (HAQ) measures disability and is based on the
measure used in the National Health Survey (27). Reported
internal consistency and test–retest reliabilities for health
distress, global health, activities limitation, and HAQ measures ranged from 0.85– 0.92 (24 –27). Depression was
measured with the Patient Health Questionnaire, a 9-item
self-administered version of the PRIME-MD developed to
screen for depression in a medical office setting (28).
Three health-related behaviors were measured: stretching and strengthening exercise, aerobic exercise, and the
use of techniques to improve communication with doctors. These instruments were developed and validated by
the Stanford Patient Education Research Center (29).
Four medical care utilization measures were used: selfreported outpatient visits to physicians, emergency room
visits, number of nights in the hospital, and number of
hospitalizations. In a previous study, Ritter et al found that
self-report of outpatient visits (r ⫽ 0.70) and days in the
hospital (r ⫽ 0.83) correlated with chart audit data (30).
We also measured perceived self-efficacy, i.e., partici-
869
pants’ confidence to manage their arthritis. The short (8item) scale was built on an earlier model (31), and it has a
Cronbach’s alpha of 0.94.
Detailed information about these instruments, including
their psychometric properties, can be found at the Stanford Patient Education Research Center Web site (29). The
psychometric properties of the Spanish-language instruments are described in detail by González et al (32,33).
Additional variables. Demographic variables included
age, sex, years of education, marital status, and race/ethnicity. Participants were also asked about their arthritis
diagnosis or condition and how much they used and how
useful they found the various Tool Kit materials. Use and
usefulness items were developed for this study. Participants were asked to indicate whether they used each resource in the Tool Kit never, a few times, several times, or
regularly. They were asked to rate the usefulness of the
materials on a scale of 0 –10 (not at all useful to very
useful).
Statistical analyses. Based on prior studies of the smallgroup ASMP, we hypothesized that program participants,
in comparison with those randomized to the control
group, would experience better outcomes at 4 months for
health status measures, health behaviors, and arthritis selfefficacy, and would also have reductions in medical care
utilization variables. It was further hypothesized that these
differences would be maintained 9 months after entry into
the program.
T-tests were used to compare baseline demographic and
outcome variables for the intervention participants with
those for the usual-care controls, and to compare the
4-month and 9-month dropouts from data collection with
those who completed questionnaires. An analysis of covariance (ANCOVA) was used to compare the intervention
effect (treatment versus control) at 4 months after controlling for the baseline value of the outcome variable. All
analyses were performed using only cases with data at 4
months and with all cases. The all-case analysis assumed
that those not completing the 4-month questionnaires had
no change from baseline (intent-to-treat). The sample was
then segmented by language group, English or Spanish,
and analyzed separately. The analyses were repeated to
look at outcomes at 9 months after controlling for baseline
values. Means and percentages were computed on all use
and usefulness variables.
To establish the clinical meaningfulness of statistically
significant changes, we also examined how many of the 7
health status outcomes improved by an effect size of ⱖ0.30
(defined as the change score over the pooled SD of the
baseline score) at 4 months for each individual. Fischer et
al found that an effect size of 0.30 was personally important for people with chronic conditions (21). We also identified participants with ⱖ3 improvements of an effect size
of ⱖ0.30. Three or more improvements is the criterion we
have used in previous studies (34,35). Treatment participants were compared with control participants using ttests for the sum of improvements. Chi-square tests were
computed to compare treatment and control improve-
870
ments of an effect size of ⱖ0.30, and participants who
had ⱖ3 versus ⬍3 improvements of an effect size of 0.3.
All data analyses were performed using SAS, version 9.1
(36).
RESULTS
Participants. After 921 participants completed informed consent forms and baseline questionnaires, they
were randomized to usual-care control (n ⫽ 463) and intervention (n ⫽ 458) groups. Of these, 414 (89%) usualcare and 359 (78%) intervention participants completed
4-month questionnaires. Nine-month questionnaires were
completed by 648 (70%) participants (Figure 1).
The mean ages of the participants were 54.3 years for the
intervention group and 53.4 years for the control group.
The mean numbers of years of education were 13.6 for the
intervention group and 13.9 for the control group. Approximately 15% of both groups were men, and ⬃50% were
married (Table 1). There were no significant differences in
any of the demographic variables between the control and
intervention groups. Means were also comparable between
language groups, although Spanish speakers were 2–3
years less educated than English speakers. A total of 546
participants (51%) reported having osteoarthritis, 238
(33%) reported having rheumatoid arthritis, 441 (30%)
reported having fibromyalgia, and 120 (13.5%) reported
having other arthritic conditions, including those who met
the CDC criteria for chronic joint symptoms. Of the English-speaking participants, 14 –16% reported having fibromyalgia alone; far fewer Spanish-speaking participants (4 –5%) did so. The average number of comorbidities
was 1.
Goeppinger et al
When the 4-month treatment noncompleters (n ⫽ 49)
were compared with 4-month control noncompleters (n ⫽
99), the controls were more likely to be Spanish speakers
(P ⫽ 0.021) and have higher health distress at baseline
than the treatment noncompleters (P ⫽ 0.024). All other
outcome variables were similar at baseline for treatment
and control participants.
When the 9-month treatment dropouts (n ⫽ 131) were
compared with control dropouts (n ⫽ 143) at baseline, the
only significant differences were that the treatment dropouts were more likely to be non-Hispanic African Americans and English speakers (P ⫽ 0.035). There were no
significant differences in the outcome variables.
Four-month outcomes. Changes in all health status variables were in the hypothesized direction, with 6 of 7
variables being significantly different between treatment
and control groups after correcting for multiple comparisons. Changes in all 3 health behaviors were also in the
hypothesized direction and statistically significant, as was
the change in self-efficacy. There were no significant differences in medical care utilization variables. When ANCOVAs were rerun using intent-to-treat methodology (last
value substituting for missing data), the results were
nearly identical. Table 3 shows the mean change scores
from the actual (non-missing) cases and the associated P
Baseline. Table 2 shows the means at baseline for the
outcome variables. Only communication with a physician
and nights in the hospital were significantly different between experimental and control participants (P ⫽ 0.019
and 0.032, respectively). After applying Bonferroni corrections, neither was significantly different.
Instrument reliability. When Cronbach’s alphas were
computed for multi-item health status instruments, the
results were consistent with previous results (23–27). For
English speakers, the Cronbach’s alphas were 0.93, 0.86,
0.91, and 0.92 for activities limitation, HAQ disability,
health distress, and self-efficacy, respectively. For Spanish
speakers, the Cronbach’s alphas were 0.91, 0.87, 0.88,
and 0.95 for activities limitation, HAQ disability, health
distress, and self-efficacy, respectively. The newer Patient
Health Questionnaire depression scale had an internal
consistency reliability of 0.90 in English and 0.87 in Spanish.
Noncompleters. Those who failed to complete the
4-month questionnaire were younger and more likely to be
English speakers than those who completed the questionnaires (P ⬍ 0.01). They also had statistically significant
higher levels of depression and fatigue and did less aerobic
exercise (P ⫽ 0.01, 0.03, and 0.01, respectively).
Figure 1. Flow chart of study participants. * The large number of
Spanish speakers who left contact information but then did not
participate reflects less available program space than interest in
the Spanish-language arm of the intervention. Participation was
offered on a first-come, first-serve basis. Sp ⫽ Spanish; Eng ⫽
English.
Mailed Arthritis Self-Management Tool Kit
871
Table 1. Baseline demographic and disease variables*
Total
Age, mean ⫾ SD (median)
years (range 18–95)
Education, mean ⫾ SD years
(range 2–23)
Men
Married
Non-Hispanic white
Non-Hispanic African
American
Hispanic
Osteoarthritis
Rheumatoid arthritis
Fibromyalgia
Only fibromyalgia
Chronic joint symptoms
Any other arthritic condition
Comorbidities, mean ⫾ SD
(range 0–6)
English speakers
Spanish speakers
Treatment
(n ⴝ 458)
Control
(n ⴝ 463)
Treatment
(n ⴝ 294)
Control
(n ⴝ 292)
Treatment
(n ⴝ 164)
Control
(n ⴝ 171)
54.3 ⫾ 12.2
(54.4)
13.6 ⫾ 3.83
53.4 ⫾ 12.3
(53.8)
13.9 ⫾ 3.80
56.3 ⫾ 11.7
(55.9)
14.8 ⫾ 2.98
55.3 ⫾ 12.0
(55.7)
15.1 ⫾ 2.99
51.1 ⫾ 12.3
(49.7)
11.6 ⫾ 4.31
50.2 ⫾ 12.0
(51.8)
12.0 ⫾ 4.25
15.4
54.0
43.7
17.2
13.8
53.2
43.6
16.6
8.2
56.1
68.0
26.9
8.6
52.2
69.2
26.4
28.0
60.4
0
0
22.8
58.5
0
0
36.7
50.4
33.8
27.9
10.5
⬍1.0
17.5
1.15 ⫾ 1.22
38.0
52.4
32.9
32.1
11.9
1.0
17.8
1.30 ⫾ 1.30
1.4
63.9
21.1
37.8
13.9
1.0
14.0
1.33 ⫾ 1.26
1.7
64.4
22.3
44.9
15.8
1.0
13.7
1.52 ⫾ 1.39
100
26.2
56.7
10.4
4.3
0
25.0
0.49 ⫾ 0.50
100
32.0
50.9
10.5
5.3
0
25.7
0.51 ⫾ 0.50
* Values are the percentage unless otherwise indicated.
values. When we segmented the sample by language
group, the group results were substantially the same as the
overall group (Table 3).
All outcome analyses were repeated using change scores
and simple t-tests instead of ANCOVAS. Statistically sig-
nificant improvements were identical, although the outcome for communication with a doctor was stronger using
t-tests (P ⬍ 0.001) rather than ANCOVAS (P ⫽ 0.017). As
noted, the differences between the treatment and control
groups for communication with a doctor at baseline were
Table 2. Baseline values of outcome variables*
Range,
desirable
direction
Health distress
Activity limitation
General health
Disability
Depression (PHQ scale)
Pain, visual numeric scale
Fatigue, visual numeric
scale
Arthritis self-efficacy
Aerobic exercise,
minutes/week
Range of motion exercise,
minutes/week
Communication with
a doctor
Physician visits, past
4 months
Emergency department
visits, past 4 months
Hospitalizations,
past 4 months
Nights in the hospital,
past 4 months
Total
Treatment
(n ⴝ 458)
English speakers
Control
(n ⴝ 463)
Treatment
(n ⴝ 294)
Control
(n ⴝ 292)
Spanish speakers
Treatment
(n ⴝ 164)
Control
(n ⴝ 171)
0–5, 2
2.72 ⫾ 1.36
2.71 ⫾ 1.33
2.39 ⫾ 1.30
2.32 ⫾ 1.23
3.33 ⫾ 1.24
3.37 ⫾ 1.22
0–4, 2
2.04 ⫾ 1.14
2.06 ⫾ 1.07
1.98 ⫾ 1.15
2.13 ⫾ 1.06
2.14 ⫾ 1.10
1.96 ⫾ 1.07
1–5, 2
3.33 ⫾ 0.957 3.44 ⫾ 0.943 3.11 ⫾ 0.890 3.30 ⫾ 0.906 3.73 ⫾ 0.942 3.66 ⫾ 0.965
0–3, 2 0.652 ⫾ 0.496 0.636 ⫾ 0.489 0.561 ⫾ 0.455 0.598 ⫾ 0.453 0.840 ⫾ 0.513 0.727 ⫾ 0.528
0–27, 2 10.2 ⫾ 6.59
9.79 ⫾ 6.41
9.80 ⫾ 6.79
9.41 ⫾ 6.41
10.8 ⫾ 6.19
10.4 ⫾ 6.36
0–10, 2 6.93 ⫾ 2.26
6.92 ⫾ 2.27
6.60 ⫾ 2.16
6.69 ⫾ 2.11
7.54 ⫾ 2.28
7.30 ⫾ 2.47
0–10, 2 6.39 ⫾ 2.60
6.43 ⫾ 2.55
6.17 ⫾ 2.57
6.42 ⫾ 2.36
6.79 ⫾ 2.61
6.44 ⫾ 2.85
1–10, 1
1
5.12 ⫾ 2.24
85.5 ⫾ 101
5.19 ⫾ 2.26
95.0 ⫾ 109
5.05 ⫾ 2.20
93.3 ⫾ 111
5.10 ⫾ 2.13
95.9 ⫾ 104
5.27 ⫾ 2.31
71.4 ⫾ 78.1
5.34 ⫾ 2.46
93.6 ⫾ 118
1
41.0 ⫾ 52.9
43.9 ⫾ 55.3
46.0 ⫾ 54.8
45.8 ⫾ 55.1
32.0 ⫾ 48.1
40.1 ⫾ 55.4
0–5, 1
2.70 ⫾ 1.32
2.90 ⫾ 1.30
3.01 ⫾ 1.24
3.12 ⫾ 1.21
2.14 ⫾ 1.27
2.52 ⫾ 1.37
0–50
3.83 ⫾ 5.09
4.38 ⫾ 5.87
4.60 ⫾ 5.75
5.48 ⫾ 6.81
2.46 ⫾ 3.20
2.53 ⫾ 2.96
0–20
0.359 ⫾ 1.22
0–3
0.103 ⫾ 0.351 0.148 ⫾ 0.550 0.099 ⫾ 0.342 0.071 ⫾ 0.270 0.110 ⫾ 0.368 0.275 ⫾ 0.812
0–12
0.273 ⫾ 1.21
0.313 ⫾ 0.832 0.399 ⫾ 1.44
0.657 ⫾ 3.64
0.251 ⫾ 0.718 0.287 ⫾ 0.716 0.415 ⫾ 0.987
0.344 ⫾ 1.457 0.502 ⫾ 3.30
* Values are the mean ⫾ SD unless otherwise indicated. PHQ ⫽ Patient Health Questionnaire.
0.146 ⫾ 0.589 0.918 ⫾ 4.15
⫺0.092 ⫾ 1.05
⫺0.060 ⫾ 0.823
0.00 ⫾ 0.719
0.026 ⫾ 0.343
0.166 ⫾ 4.30
⫺0.488 ⫾ 2.02
⫺0.237 ⫾ 2.17
0.088 ⫾ 2.07
⫺7.37 ⫾ 103
3.05 ⫾ 62.2
⫺0.010 ⫾ 1.05
⫺0.362 ⫾ 4.62
⫺0.018 ⫾ 0.982
⫺0.012 ⫾ 0.576
⫺0.086 ⫾ 4.84
⫺0.529 ⫾ 1.16
⫺0.389 ⫾ 0.965
⫺0.059 ⫾ 0.759
⫺0.100 ⫾ 0.357
⫺1.45 ⫾ 5.07
⫺1.23 ⫾ 2.26
⫺0.807 ⫾ 2.38
0.837 ⫾ 2.28
40.2 ⫾ 119
24.2 ⫾ 68.1
0.262 ⫾ 1.15
0.009 ⫾ 4.77
⫺0.057 ⫾ 0.891
0.063 ⫾ 1.01
0.140 ⫾ 2.21
* Values are the change ⫾ SD. PHQ ⫽ Patient Health Questionnaire.
† From analyses of covariance.
Health distress
Activity limitation
General health
Disability
Depression (PHQ
scale)
Pain, visual
numeric scale
Fatigue, visual
numeric scale
Arthritis selfefficacy
Aerobic exercise,
minutes/week
Range of motion
exercise,
minutes/week
Communication
with a doctor
Physician visits,
past 4 months
Emergency
department
visits, past 4
months
Hospitalizations,
past 4 months
Nights in the
hospital, past 4
months
Control
(n ⴝ 414)
Treatment
(n ⴝ 359)
Total
0.638
0.527
0.461
0.987
0.017
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
0.039
⬍ 0.001
⬍ 0.001
P†
0.126 ⫾ 2.45
0.101 ⫾ 1.26
⫺0.048 ⫾ 0.947
⫺0.010 ⫾ 5.53
0.213 ⫾ 1.03
11.9 ⫾ 59.5
31.7 ⫾ 113
0.902 ⫾ 2.18
⫺0.451 ⫾ 2.05
⫺1.01 ⫾ 1.99
⫺0.391 ⫾ 1.02
⫺0.344 ⫾ 0.864
⫺0.024 ⫾ 0.725
⫺0.059 ⫾ 0.300
⫺1.35 ⫾ 4.68
Treatment
(n ⴝ 215)
0.071 ⫾ 5.12
0.024 ⫾ 0.401
0.036 ⫾ 1.08
⫺0.400 ⫾ 5.37
⫺0.010 ⫾ 0.963
⫺2.88 ⫾ 55.2
⫺11.0 ⫾ 94.2
0.046 ⫾ 1.90
⫺0.050 ⫾ 1.960
⫺0.355 ⫾ 1.85
0.045 ⫾ 0.988
⫺0.034 ⫾ 0.789
0.019 ⫾ 0.708
0.031 ⫾ 0.294
0.354 ⫾ 4.03
Control
(n ⴝ 261)
English speakers
Table 3. Four-month change scores*
0.989
0.251
0.689
0.789
0.046
⬍ 0.001
⬍ 0.001
⬍ 0.001
0.002
⬍ 0.001
⬍ 0.001
0.003
0.253
⬍ 0.001
⬍ 0.001
P†
0.159 ⫾ 1.81
0.007 ⫾ 0.418
⫺0.069 ⫾ 0.8080
0.007 ⫾ 3.40
0.333 ⫾ 1.32
42.6 ⫾ 75.9
52.8 ⫾ 126
0.740 ⫾ 2.43
⫺1.33 ⫾ 2.72
⫺1.55 ⫾ 2.58
⫺0.734 ⫾ 1.33
⫺0.457 ⫾ 1.10
⫺0.182 ⫾ 0.793
⫺0.160 ⫾ 0.422
⫺1.60 ⫾ 5.61
Treatment
(n ⴝ 144)
⫺0.346 ⫾ 4.33
⫺0.072 ⫾ 0.779
⫺0.105 ⫾ 0.804
⫺0.300 ⫾ 3.05
⫺0.011 ⫾ 1.19
13.1 ⫾ 71.76
⫺1.18 ⫾ 117
0.159 ⫾ 2.33
⫺0.556 ⫾ 2.46
⫺0.712 ⫾ 2.26
⫺0.325 ⫾ 1.10
⫺0.103 ⫾ 0.878
⫺0.032 ⫾ 0.738
0.016 ⫾ 0.379
⫺0.150 ⫾ 4.72
Control
(n ⴝ 153)
Spanish speakers
0.470
0.563
0.601
0.451
0.194
0.002
0.001
0.034
0.015
0.003
⬍ 0.001
⬍ 0.001
0.082
⬍ 0.001
0.015
P†
872
Goeppinger et al
Mailed Arthritis Self-Management Tool Kit
873
Table 4. Nine-month change scores*
Total (n ⴝ 648)
Health distress
Activity limitation
General health
Disability
Depression (Patient Health
Questionnaire scale)
Pain, visual numeric scale
Fatigue, visual numeric scale
Arthritis self-efficacy
Aerobic exercise, minutes/week
Range of motion exercise,
minutes/week
Communication with a doctor
Physician visits, past 4 months
Emergency department visits,
past 4 months
Hospitalizations, past 4 months
Nights in the hospital, past 4
months
English speakers (n ⴝ 398)
Spanish speakers (n ⴝ 250)
Change ⴞ SD
P*
Change ⴞ SD
P*
Change ⴞ SD
P*
⫺0.580 ⫾ 1.15
⫺0.460 ⫾ 1.01
⫺0.120 ⫾ 0.772
⫺0.106 ⫾ 0.388
⫺1.96 ⫾ 5.10
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⫺0.432 ⫾ 1.01
⫺0.445 ⫾ 0.925
⫺0.030 ⫾ 0.739
⫺0.076 ⫾ 0.347
⫺1.94 ⫾ 4.94
⬍ 0.001
⬍ 0.001
0.413
⬍ 0.001
⬍ 0.001
⫺0.813 ⫾ 1.32
⫺0.482 ⫾ 1.13
⫺0.260 ⫾ 0.802
⫺0.163 ⫾ 0.439
⫺2.01 ⫾ 5.36
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⫺1.27 ⫾ 2.34
⫺0.859 ⫾ 2.52
0.869 ⫾ 2.28
32.1 ⫾ 114
20.3 ⫾ 66.0
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⫺1.09 ⫾ 2.06
⫺0.698 ⫾ 2.06
0.941 ⫾ 2.22
23.0 ⫾ 98.6
13.9 ⫾ 59.6
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⫺1.54 ⫾ 2.69
⫺1.11 ⫾ 3.08
0.755 ⫾ 2.38
46.7 ⫾ 133
30.4 ⫾ 73.9
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
⬍ 0.001
0.304 ⫾ 1.13
⫺0.268 ⫾ 4.97
⫺0.079 ⫾ 0.783
⬍ 0.001
0.157
0.011
0.320 ⫾ 1.06
⫺0.432 ⫾ 5.64
⫺0.065 ⫾ 0.803
⬍ 0.001
0.154
0.113
0.280 ⫾ 1.22
⫺0.016 ⫾ 3.70
⫺0.100 ⫾ 0.751
⬍ 0.001
0.946
0.036
0.009 ⫾ 0.565
0.047 ⫾ 2.41
0.673
0.622
0.065 ⫾ 0.572
0.204 ⫾ 2.89
0.026
0.166
⫺0.076 ⫾ 0.543
⫺0.196 ⫾ 1.33
0.028
0.021
* From t-tests comparing the change score with zero change.
not statistically significant after taking into account multiple comparisons.
Nine-month outcomes. After 4 months of waiting, control participants were sent the same intervention materials
(the Arthritis Self-Management Tool Kit) as treatment participants. All participants were asked to complete a questionnaire 9 months after receiving the materials. Of those
originally randomized, 70% completed the questionnaire
(Table 4). When t-tests were used to compare baseline
values with the values of the outcome variables at 9
months, the 7 health indicators, the 3 health behaviors,
and arthritis self-efficacy were significantly improved at 9
months (Table 4). There were no significant changes in
health care utilization after taking into account multiple
comparisons, but emergency department visits were marginally reduced (P ⫽ 0.012). The statistically significant
tests using intent-to-treat methodology were nearly identical to the same tests using only those who completed
9-month questionnaires. When the data were broken down
by language group, once again Spanish and English speakers showed the same results as the overall sample, with the
exception that overall general health was not significantly
improved for Spanish speakers.
Additional analyses. Clinically meaningful change.
Statistical improvements of an effect size of ⱖ0.30 for ⱖ3
of the 7 health indicators were considered clinically meaningful. At 4 months, 55% of treatment participants met
this criterion compared with 34% of control participants
(chi-square P ⬍ 0.001). The mean number of improvements at 4 months of an effect size of ⱖ0.30 among the 7
health indicators was 2.9 for the treatment participants
and 2.0 for the usual-care control participants (P ⬍ 0.001).
Table 5 shows the proportion of treatment and control
participants who improved by an effect size of ⱖ0.30 for
each of the 7 health indicators at 4 months. After taking
into account multiple comparisons, the difference between treatment and control group participants is significant for 6 of the 7 outcomes.
Use of the materials. Four months after receiving the
Tool Kit, participants were asked how they used the materials and what they found useful. Only 3% of participants reported not using any of the materials.
Participants who used the Tool Kit found it useful
(mean ⫾ SD 7.40 ⫾ 2.51). The proportion of the participants who used the different types of materials at least
some of the time varied from 95% for the book to 69% for
the exercise CD. The book was rated the most useful of the
materials, with only 3% of the participants finding it not
useful. In contrast, the exercise and relaxation CDs were
Table 5. Percentage of participants who improved by
effect sizes of >0.30 for each health indicator variable
(4 months)
Variable
Health distress
Activity limitation
General health
Disability
Depression (Patient
Health Questionnaire
scale)
Pain, visual numeric
scale
Fatigue, visual numeric
scale
P
(treatment
Treatment Control vs. control)
52.6
46.9
24.5
34.9
23.8
33.2
26.9
18.0
20.6
15.4
⬍ 0.001
⬍ 0.001
0.029
⬍ 0.001
0.003
59.4
45.1
⬍ 0.001
51.1
38.2
⬍ 0.001
874
not useful for 19% and 13% of the participants, respectively. The Spanish speakers were the most likely to find
every component of the Tool Kit helpful.
DISCUSSION
CDC-funded state arthritis programs are not required, nor
do they have the resources, to participate in research.
Consequently, it is not surprising that they had limited
success in recruiting participants. This finding contributed
to the CDC decision to embed the dissemination of arthritis self-management intervention programs in existing program delivery systems like Arthritis Foundation chapters,
and to reconsider how programs could be promoted
through public health systems.
The hypotheses that there would be improvement in all
outcome variables at 4 and 9 months after receiving the
materials were partially confirmed. There were significant
improvements in health status variables, health behaviors,
and arthritis self-efficacy, but not in health care utilization.
The results were similar for Spanish-speaking participants and English-speaking non-Hispanic whites, although there was insufficient power among non-Hispanic
African Americans to adequately test the significance of
the changes in outcomes. All changes except for the
change in self-reported general health were in the expected direction at both 4 and 9 months and are comparable with the findings of Goeppinger and colleagues among
a largely African American sample (15).
These findings suggest that an arthritis self-management
intervention, packaged in a Tool Kit and sent to participants in a single mailing, was as effective as previously
studied intervention delivery modalities (37). A single
mailing reached younger participants and better educated
Spanish speakers, both with fewer comorbidities, than the
small-group ASMP (15,38).
Based on the results of this study, Arthritis Foundation
chapters, public health agencies, and health care practitioners can confidently promote both the small-group ASMP
and mail-delivered Tool Kit interventions (Arthritis SelfManagement Tool Kit; Bull Publishing Company, Boulder,
CO). The Tool Kit reached not only working-age populations where small-group interventions may be less feasible, but also a better educated Spanish-speaking sample
than in earlier effectiveness trials. The Tool Kit may also
be useful for organizations with limited financial or programmatic resources for dissemination. The availability
and efficacy of the Tool Kit in Spanish and English also
enhances its value. The CDC Arthritis Program has listed
the Tool Kit as a “promising practice” and allows funded
state health departments to use federal monies to support
dissemination.
The main limitations of this study are methodologic.
Our inability to enroll the targeted number of African
American participants suggests that our recruitment methods may have been inappropriate or the mailed Tool Kit
format unappealing. Barriers to research participation by
African Americans are well-documented and may have
also been causes (39). A future study of the program might
target non-Hispanic African Americans and use the recruitment strategies we found most successful.
Goeppinger et al
Because participants could not be blinded to the intervention, we cannot rule out the possibility of an attention
effect. It is unlikely, however, that a one-time mailing
would have sustained attention effects for 9 months. We
also cannot entirely rule out that differential health among
noncompleters of questionnaires had an effect on the results, particularly at 9 months, when there is no longer a
randomized control group. At 4 months, the relative similarity at baseline between the treatment and control noncompleters suggests that this is unlikely to be a serious
problem. Nine-month results must be seen more cautiously.
Examining 15 outcome variables increased the risk of
Type I error, but the overall consistency of the effectiveness results suggests that Type I error was unlikely. The
differences in change scores at 4 months and 9 months for
all but medical utilization measures favored the treatment
group, and all scores except self-reported general health
and communication with a physician at 4 months were
significant at P ⬍ 0.001.
Utilizing ANCOVAS to present 4-month results controlling for baseline values of outcome variables was a more
conservative approach than using t-tests, although it did
not affect any variables except for communication with a
doctor. The change in this variable was statistically significant in both the English and Spanish subsamples using
t-tests, but not when using ANCOVAS.
It should be noted that, although statistically and even
clinically significant, some improvements are modest. The
question remains: do they have clinical meaning? We
think that they do. The study sample is very heterogeneous
on all demographic and disease variables. In addition,
there were no exclusion criteria based on symptom severity. Many study participants probably enrolled with low
levels of symptom severity and therefore had little room
for improvement (floor effect). All of these factors influence effect sizes. Fifty-five percent of the treatment group
reported improvements of an effect size of ⱖ0.30 for 3 or
more of the 7 health indicators. Participants also reported
that the materials were useful. Given these findings, it is
important that the mailed Tool Kit be included in the
approved list of evidence-based arthritis self-management
interventions.
ACKNOWLEDGMENTS
We gratefully acknowledge the able assistance of Teresa J.
Brady, PhD, our Technical Monitor at the CDC; Katy Plant,
MPH, who helped develop the English-language exercise
CDs and the personalized CD recordings of the information
sheets included in the Arthritis Self-Management Tool Kit;
Virginia González, who developed the Spanish-language
information sheets; and Janice Pigg, MSN, who energetically recruited respondents for the needs assessment.
AUTHOR CONTRIBUTIONS
All authors were involved in contributions to study conception
and design, acquisition of data, or analysis and interpretation of
data, and drafting the article or revising it critically for important
intellectual content, and all authors approved the final version to
be submitted for publication. Dr. Goeppinger had full access to all
Mailed Arthritis Self-Management Tool Kit
of the data in the study and takes responsibility for the integrity of
the data and the accuracy of the data analysis.
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