Trial Outcomes & Findings for FAMS Mobile Health Intervention for Diabetes Self-care Support (NCT NCT02481596)
NCT ID: NCT02481596
Last Updated: 2019-11-27
Results Overview
as measured by Personal Diabetes Questionnaire Use of Dietary Information for Decision Making (1=less use of information - worse to 6=more use of information - better)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
512 participants
Primary outcome timeframe
3 months, 6 months
Results posted on
2019-11-27
Participant Flow
5 subjects were never reached for a required conversation prior to starting the text messaging program--they were withdrawn by the PI. 1 subject was withdrawn by the PI due to problematic behavior during enrollment.
Participant milestones
| Measure |
REACH + FAMS
Participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months.
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
|
REACH
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors).
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
Helpline \& A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline & A1c Results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline \& A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
126
|
127
|
253
|
|
Overall Study
COMPLETED
|
123
|
126
|
245
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FAMS Mobile Health Intervention for Diabetes Self-care Support
Baseline characteristics by cohort
| Measure |
REACH + FAMS
n=126 Participants
Participants will receive FAMS components (monthly phone coaching and text messages supporting goal set in coaching, plus the option to invite a support person to receive text messages) for six months.
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
|
REACH
n=127 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors).
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
|
Helpline & A1c Results
n=253 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
|
Total
n=506 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=39 Participants
|
109 Participants
n=41 Participants
|
206 Participants
n=35 Participants
|
412 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
94 Participants
n=31 Participants
|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 10.2 • n=39 Participants
|
55.8 years
STANDARD_DEVIATION 9.4 • n=41 Participants
|
56.1 years
STANDARD_DEVIATION 9.4 • n=35 Participants
|
55.9 years
STANDARD_DEVIATION 9.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=39 Participants
|
70 Participants
n=41 Participants
|
135 Participants
n=35 Participants
|
274 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=39 Participants
|
57 Participants
n=41 Participants
|
118 Participants
n=35 Participants
|
232 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
31 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=39 Participants
|
116 Participants
n=41 Participants
|
224 Participants
n=35 Participants
|
451 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=39 Participants
|
51 Participants
n=41 Participants
|
98 Participants
n=35 Participants
|
198 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
128 Participants
n=35 Participants
|
255 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
27 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=39 Participants
|
127 participants
n=41 Participants
|
253 participants
n=35 Participants
|
506 participants
n=31 Participants
|
|
Problem eating behaviors - Personal Diabetes Questionnaire
|
3.3 units on a scale
n=39 Participants
|
3.3 units on a scale
n=41 Participants
|
3.3 units on a scale
n=35 Participants
|
3.3 units on a scale
n=31 Participants
|
|
Use of dietary information - Personal Diabetes Questionnaire
|
2.7 units on a scale
n=39 Participants
|
3.0 units on a scale
n=41 Participants
|
2.7 units on a scale
n=35 Participants
|
3.0 units on a scale
n=31 Participants
|
|
MET-minutes per week - International Physical Activity Questionnaire-short form
|
1158 MET-minutes per week
n=39 Participants
|
1448 MET-minutes per week
n=41 Participants
|
1299 MET-minutes per week
n=35 Participants
|
1352 MET-minutes per week
n=31 Participants
|
|
Helpful involvement - Family and Friend Involvement in Adults' Diabetes
|
1.8 units on a scale
n=39 Participants
|
1.6 units on a scale
n=41 Participants
|
1.9 units on a scale
n=35 Participants
|
1.8 units on a scale
n=31 Participants
|
|
Harmful involvement - Family and Friend Involvement in Adults' Diabetes
|
1.6 units on a scale
n=39 Participants
|
1.6 units on a scale
n=41 Participants
|
1.6 units on a scale
n=35 Participants
|
1.6 units on a scale
n=31 Participants
|
|
Diabetes self-efficacy - Perceived Diabetes Self-Management Scale
|
14 units on a scale
n=39 Participants
|
14 units on a scale
n=41 Participants
|
14 units on a scale
n=35 Participants
|
14 units on a scale
n=31 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsas measured by Personal Diabetes Questionnaire Use of Dietary Information for Decision Making (1=less use of information - worse to 6=more use of information - better)
Outcome measures
| Measure |
REACH + FAMS
n=126 Participants
REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
|
REACH
n=127 Participants
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
|
Helpline & A1c Results
n=253 Participants
Helpline \& A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Adherence to Diet - Use of Dietary Information
3 months
|
3.0 score on a scale
Interval 1.7 to 4.3
|
3.3 score on a scale
Interval 1.7 to 4.3
|
2.7 score on a scale
Interval 1.0 to 4.0
|
|
Adherence to Diet - Use of Dietary Information
6 months
|
3.3 score on a scale
Interval 2.0 to 4.3
|
3.3 score on a scale
Interval 2.0 to 4.7
|
2.7 score on a scale
Interval 1.3 to 4.3
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsas measured by International Physical Activity Questionnaire-Short form \[metabolic equivalent minutes (MET-minutes) per week\] where more MET-minutes per week indicates more physical activity
Outcome measures
| Measure |
REACH + FAMS
n=126 Participants
REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
|
REACH
n=127 Participants
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
|
Helpline & A1c Results
n=253 Participants
Helpline \& A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Adherence to Exercise
6 months
|
1293 MET-minutes per week
Interval 558.0 to 3120.0
|
1000 MET-minutes per week
Interval 273.0 to 2240.0
|
1295 MET-minutes per week
Interval 438.0 to 2549.0
|
|
Adherence to Exercise
3 months
|
1251 MET-minutes per week
Interval 510.0 to 2691.0
|
977 MET-minutes per week
Interval 248.0 to 2799.0
|
1187 MET-minutes per week
Interval 438.0 to 3210.0
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsas measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse)
Outcome measures
| Measure |
REACH + FAMS
n=126 Participants
REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
|
REACH
n=127 Participants
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
|
Helpline & A1c Results
n=253 Participants
Helpline \& A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Adherence to Diet - Problem Eating Behavior
3 months
|
3.3 score on a scale
Interval 2.7 to 3.7
|
3.0 score on a scale
Interval 2.3 to 3.7
|
3.0 score on a scale
Interval 2.7 to 4.0
|
|
Adherence to Diet - Problem Eating Behavior
6 months
|
3.3 score on a scale
Interval 2.7 to 3.7
|
3.0 score on a scale
Interval 2.3 to 3.7
|
3.0 score on a scale
Interval 2.7 to 4.0
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsas measured by Family and Friend Involvement in Adults' Diabetes (FIAD) helpful involvement subscale ranging from 1= less frequent helpful involvement (worse) to 5=more frequent helpful involvement (better)
Outcome measures
| Measure |
REACH + FAMS
n=126 Participants
REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
|
REACH
n=127 Participants
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
|
Helpline & A1c Results
n=253 Participants
Helpline \& A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Supportive Family Behaviors
3 months
|
1.8 units on a scale
Interval 1.4 to 2.7
|
1.6 units on a scale
Interval 1.1 to 2.3
|
1.8 units on a scale
Interval 1.2 to 2.6
|
|
Supportive Family Behaviors
6 months
|
1.8 units on a scale
Interval 1.3 to 2.7
|
1.6 units on a scale
Interval 1.0 to 2.4
|
1.7 units on a scale
Interval 1.2 to 2.4
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsas measured by Family and Friend Involvement in Adults' Diabetes (FIAD) harmful involvement subscale ranging from 1= less frequent harmful involvement (better) to 5=more frequent harmful involvement (worse)
Outcome measures
| Measure |
REACH + FAMS
n=126 Participants
REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
|
REACH
n=127 Participants
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
|
Helpline & A1c Results
n=253 Participants
Helpline \& A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Obstructive Family Behaviors
3 months
|
1.4 score on a scale
Interval 1.1 to 1.9
|
1.4 score on a scale
Interval 1.1 to 1.9
|
1.6 score on a scale
Interval 1.1 to 2.0
|
|
Obstructive Family Behaviors
6 months
|
1.3 score on a scale
Interval 1.0 to 1.9
|
1.4 score on a scale
Interval 1.1 to 1.7
|
1.4 score on a scale
Interval 1.1 to 1.9
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsas measured by scores on the Perceived Diabetes Self-Management Scale (4-item version) ranging from 4 = low self-efficacy (worse) to 20 = high self-efficacy (better)
Outcome measures
| Measure |
REACH + FAMS
n=126 Participants
REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
|
REACH
n=127 Participants
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
|
Helpline & A1c Results
n=253 Participants
Helpline \& A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Diabetes Self-efficacy
3 months
|
14 score on a scale
Interval 12.0 to 17.0
|
15 score on a scale
Interval 13.0 to 18.0
|
14 score on a scale
Interval 11.0 to 16.0
|
|
Diabetes Self-efficacy
6 months
|
15 score on a scale
Interval 12.0 to 17.5
|
15 score on a scale
Interval 12.0 to 18.0
|
14 score on a scale
Interval 12.0 to 16.0
|
Adverse Events
REACH + FAMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
REACH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Helpline & A1c Results
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lindsay S. Mayberry, PhD, MS
Vanderbilt University Medical Center
Phone: 615-875-5821
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place