Trial Outcomes & Findings for Improving Medication Adherence in the Alabama Black Belt (NCT NCT02274844)
NCT ID: NCT02274844
Last Updated: 2020-10-29
Results Overview
Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
473 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2020-10-29
Participant Flow
Recruitment efforts in this area focused on attending health fairs, posting flyers at community locations such as libraries and churches. The main focus of recruitment was in the county's safety net clinic.
Participant milestones
| Measure |
Peer Coaching
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
270
|
|
Overall Study
COMPLETED
|
165
|
238
|
|
Overall Study
NOT COMPLETED
|
38
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 subject in the usual care arm declined to provide this information.
Baseline characteristics by cohort
| Measure |
Peer Coaching
n=203 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=270 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 10.6 • n=203 Participants
|
56.7 years
STANDARD_DEVIATION 12.1 • n=270 Participants
|
57.1 years
STANDARD_DEVIATION 11.5 • n=473 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=203 Participants
|
212 Participants
n=270 Participants
|
371 Participants
n=473 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=203 Participants
|
58 Participants
n=270 Participants
|
102 Participants
n=473 Participants
|
|
Race/Ethnicity, Customized
African American
|
178 Participants
n=203 Participants
|
250 Participants
n=270 Participants
|
428 Participants
n=473 Participants
|
|
Race/Ethnicity, Customized
All Others
|
25 Participants
n=203 Participants
|
20 Participants
n=270 Participants
|
45 Participants
n=473 Participants
|
|
Marital Status
Married or living with partner
|
75 Participants
n=203 Participants • 1 subject in the usual care arm declined to provide this information.
|
94 Participants
n=269 Participants • 1 subject in the usual care arm declined to provide this information.
|
169 Participants
n=472 Participants • 1 subject in the usual care arm declined to provide this information.
|
|
Marital Status
Never married, divorced, widowed, separated
|
128 Participants
n=203 Participants • 1 subject in the usual care arm declined to provide this information.
|
175 Participants
n=269 Participants • 1 subject in the usual care arm declined to provide this information.
|
303 Participants
n=472 Participants • 1 subject in the usual care arm declined to provide this information.
|
|
Annual Income
<$20,000
|
133 Participants
n=193 Participants • 10 subjects in the peer coaching arm and 11 subjects in the usual care arm declined to provide this information.
|
185 Participants
n=259 Participants • 10 subjects in the peer coaching arm and 11 subjects in the usual care arm declined to provide this information.
|
318 Participants
n=452 Participants • 10 subjects in the peer coaching arm and 11 subjects in the usual care arm declined to provide this information.
|
|
Annual Income
>=$20,000
|
60 Participants
n=193 Participants • 10 subjects in the peer coaching arm and 11 subjects in the usual care arm declined to provide this information.
|
74 Participants
n=259 Participants • 10 subjects in the peer coaching arm and 11 subjects in the usual care arm declined to provide this information.
|
134 Participants
n=452 Participants • 10 subjects in the peer coaching arm and 11 subjects in the usual care arm declined to provide this information.
|
|
Education
< High School
|
46 Participants
n=202 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
51 Participants
n=270 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
97 Participants
n=472 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
|
Education
12th grade, GED, HS diploma
|
69 Participants
n=202 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
99 Participants
n=270 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
168 Participants
n=472 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
|
Education
>High School
|
87 Participants
n=202 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
120 Participants
n=270 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
207 Participants
n=472 Participants • 1 subject in the peer coaching arm declined to provide this information.
|
|
Employment
Employed for wages or self-employed
|
53 Participants
n=202 Participants • 1 subject in the peer coaching arm and 2 subjects in the usual care arm declined to provide this information.
|
72 Participants
n=268 Participants • 1 subject in the peer coaching arm and 2 subjects in the usual care arm declined to provide this information.
|
125 Participants
n=470 Participants • 1 subject in the peer coaching arm and 2 subjects in the usual care arm declined to provide this information.
|
|
Employment
Not worked(ret, out of wrk, homemker, unable work)
|
149 Participants
n=202 Participants • 1 subject in the peer coaching arm and 2 subjects in the usual care arm declined to provide this information.
|
196 Participants
n=268 Participants • 1 subject in the peer coaching arm and 2 subjects in the usual care arm declined to provide this information.
|
345 Participants
n=470 Participants • 1 subject in the peer coaching arm and 2 subjects in the usual care arm declined to provide this information.
|
|
HbA1c
|
8.6 %
STANDARD_DEVIATION 2.2 • n=203 Participants
|
8.3 %
STANDARD_DEVIATION 2.0 • n=270 Participants
|
8.4 %
STANDARD_DEVIATION 2.1 • n=473 Participants
|
|
Hba1c
Less than 7.0
|
73 Participants
n=203 Participants
|
114 Participants
n=270 Participants
|
187 Participants
n=473 Participants
|
|
Hba1c
7.0 or greater
|
130 Participants
n=203 Participants
|
156 Participants
n=270 Participants
|
286 Participants
n=473 Participants
|
|
Systolic Blood Pressure
|
127.8 mmHg
STANDARD_DEVIATION 19.4 • n=203 Participants
|
129.1 mmHg
STANDARD_DEVIATION 19.9 • n=270 Participants
|
128.6 mmHg
STANDARD_DEVIATION 19.7 • n=473 Participants
|
|
Body Mass Index
|
36.4 kg/m2
STANDARD_DEVIATION 8.8 • n=203 Participants
|
36.5 kg/m2
STANDARD_DEVIATION 8.0 • n=270 Participants
|
36.5 kg/m2
STANDARD_DEVIATION 8.4 • n=473 Participants
|
|
Medication Adherence Score as measured by the Morisky Medication Adherence Scale
Yes to 0 questions
|
67 Participants
n=203 Participants
|
104 Participants
n=270 Participants
|
171 Participants
n=473 Participants
|
|
Medication Adherence Score as measured by the Morisky Medication Adherence Scale
Yes to 1 questions
|
84 Participants
n=203 Participants
|
98 Participants
n=270 Participants
|
182 Participants
n=473 Participants
|
|
Medication Adherence Score as measured by the Morisky Medication Adherence Scale
Yes to 2 questions
|
34 Participants
n=203 Participants
|
40 Participants
n=270 Participants
|
74 Participants
n=473 Participants
|
|
Medication Adherence Score as measured by the Morisky Medication Adherence Scale
Yes to 3 questions
|
12 Participants
n=203 Participants
|
20 Participants
n=270 Participants
|
32 Participants
n=473 Participants
|
|
Medication Adherence Score as measured by the Morisky Medication Adherence Scale
Yes to 4 questions
|
6 Participants
n=203 Participants
|
7 Participants
n=270 Participants
|
13 Participants
n=473 Participants
|
|
Medication Adherence Score as measured by the Morisky Medication Adherence Scale
Missing
|
0 Participants
n=203 Participants
|
1 Participants
n=270 Participants
|
1 Participants
n=473 Participants
|
|
Number of Subjects Taking Insulin
|
96 Participants
n=203 Participants
|
111 Participants
n=270 Participants
|
207 Participants
n=473 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Self Reported Medication Adherence
Baseline
|
0.78 Scores on a scale
Standard Deviation 0.80
|
0.74 Scores on a scale
Standard Deviation 0.79
|
|
Change in Self Reported Medication Adherence
6 months
|
0.53 Scores on a scale
Standard Deviation 0.66
|
0.62 Scores on a scale
Standard Deviation 0.76
|
|
Change in Self Reported Medication Adherence
Change at 6 months
|
-0.25 Scores on a scale
Standard Deviation 0.70
|
-0.12 Scores on a scale
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Percentage of HbA1c
Baseline
|
8.4 percentage of HbA1c
Standard Deviation 2.11
|
8.3 percentage of HbA1c
Standard Deviation 1.99
|
|
Change in Percentage of HbA1c
6 months
|
8.1 percentage of HbA1c
Standard Deviation 1.9
|
8.1 percentage of HbA1c
Standard Deviation 1.8
|
|
Change in Percentage of HbA1c
Change at 6 months
|
-0.37 percentage of HbA1c
Standard Deviation 1.71
|
-0.24 percentage of HbA1c
Standard Deviation 1.55
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Blood Pressure
Baseline
|
128.5 mmHg
Standard Deviation 19.6
|
129.3 mmHg
Standard Deviation 19.5
|
|
Change in Blood Pressure
6 months
|
130.6 mmHg
Standard Deviation 20.7
|
133.6 mmHg
Standard Deviation 18.4
|
|
Change in Blood Pressure
Change at 6 months
|
2.5 mmHg
Standard Deviation 19.5
|
4.1 mmHg
Standard Deviation 20.5
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Finger stick, spectrophotometer to measure cholesterol level.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol
Baseline
|
84.6 mg/dL
Standard Deviation 38.4
|
80.7 mg/dL
Standard Deviation 36.3
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol
6 months
|
80.1 mg/dL
Standard Deviation 33.1
|
82.2 mg/dL
Standard Deviation 31.0
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol
Change at 6 months
|
-4.5 mg/dL
Standard Deviation 38.6
|
1.5 mg/dL
Standard Deviation 38.2
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Quality of Life as Assessed With the Short Form 12- Mental Component
Baseline
|
42.7 Scores on a scale
Standard Deviation 7.5
|
42.3 Scores on a scale
Standard Deviation 7.0
|
|
Change in Quality of Life as Assessed With the Short Form 12- Mental Component
6 months
|
42.0 Scores on a scale
Standard Deviation 6.9
|
42.1 Scores on a scale
Standard Deviation 7.2
|
|
Change in Quality of Life as Assessed With the Short Form 12- Mental Component
Change at 6 months
|
-0.7 Scores on a scale
Standard Deviation 8.6
|
-0.2 Scores on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Quality of Life as Assessed With the Short Form-12- Physical Component
Baseline
|
39.0 Scores on a scale
Standard Deviation 8.2
|
40.1 Scores on a scale
Standard Deviation 7.7
|
|
Change in Quality of Life as Assessed With the Short Form-12- Physical Component
6 months
|
40.4 Scores on a scale
Standard Deviation 8.3
|
40.4 Scores on a scale
Standard Deviation 7.9
|
|
Change in Quality of Life as Assessed With the Short Form-12- Physical Component
Change at 6 months
|
1.4 Scores on a scale
Standard Deviation 7.7
|
0.3 Scores on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
Baseline
|
31.9 Scores on a scale
Standard Deviation 5.6
|
32.2 Scores on a scale
Standard Deviation 6.0
|
|
Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
6 months
|
33.9 Scores on a scale
Standard Deviation 5.1
|
33.1 Scores on a scale
Standard Deviation 5.5
|
|
Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
Change at 6 months
|
2.0 Scores on a scale
Standard Deviation 5.6
|
0.9 Scores on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 34 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress. Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). A score of 3 or greater = moderate distress.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=236 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Diabetes-Specific Quality of Life
Baseline
|
2.6 Scores on a scale
Standard Deviation 1.3
|
2.3 Scores on a scale
Standard Deviation 1.3
|
|
Change in Diabetes-Specific Quality of Life
6 months
|
1.9 Scores on a scale
Standard Deviation 1.1
|
2.0 Scores on a scale
Standard Deviation 1.2
|
|
Change in Diabetes-Specific Quality of Life
Change at 6 months
|
-0.6 Scores on a scale
Standard Deviation 1.3
|
-0.3 Scores on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: This data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: This data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 44 participants in the peer coaching arm and 38 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Change in number of diabetes medications.
Outcome measures
| Measure |
Peer Coaching
n=159 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=232 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Diabetes Medication Counts
Baseline
|
1.4 Medications
Standard Deviation 0.7
|
1.3 Medications
Standard Deviation 0.6
|
|
Change in Diabetes Medication Counts
6 months
|
1.3 Medications
Standard Deviation 0.6
|
1.3 Medications
Standard Deviation 0.6
|
|
Change in Diabetes Medication Counts
Change at 6 months
|
-0.04 Medications
Standard Deviation 0.5
|
0.004 Medications
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
Baseline
|
10.6 Scores on a scale
Standard Deviation 2.7
|
9.8 Scores on a scale
Standard Deviation 2.8
|
|
Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
Follow-up
|
9.8 Scores on a scale
Standard Deviation 2.7
|
9.7 Scores on a scale
Standard Deviation 2.8
|
|
Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
Change
|
-0.8 Scores on a scale
Standard Deviation 2.5
|
-0.1 Scores on a scale
Standard Deviation 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
Baseline
|
13.3 Scores on a scale
Standard Deviation 3.2
|
12.7 Scores on a scale
Standard Deviation 3.4
|
|
Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
Follow-up
|
12.6 Scores on a scale
Standard Deviation 3.4
|
12.6 Scores on a scale
Standard Deviation 3.4
|
|
Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
Change
|
-0.6 Scores on a scale
Standard Deviation 3.3
|
-0.1 Scores on a scale
Standard Deviation 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
Baseline
|
19.1 Scores on a scale
Standard Deviation 3.6
|
19.6 Scores on a scale
Standard Deviation 3.9
|
|
Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
Follow-up
|
20.0 Scores on a scale
Standard Deviation 3.9
|
19.4 Scores on a scale
Standard Deviation 4.2
|
|
Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
Change
|
0.9 Scores on a scale
Standard Deviation 3.5
|
-0.2 Scores on a scale
Standard Deviation 3.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsPopulation: 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time.
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Outcome measures
| Measure |
Peer Coaching
n=164 Participants
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Usual Care
n=239 Participants
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.
|
|---|---|---|
|
Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
Baseline
|
15.4 Scores on a scale
Standard Deviation 3.9
|
14.9 Scores on a scale
Standard Deviation 4.2
|
|
Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
Follow-up
|
14.0 Scores on a scale
Standard Deviation 3.8
|
14.7 Scores on a scale
Standard Deviation 8.9
|
|
Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
Change
|
-1.5 Scores on a scale
Standard Deviation 4.0
|
-0.2 Scores on a scale
Standard Deviation 3.9
|
Adverse Events
Peer Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place