Trial Outcomes & Findings for Harnessing mHealth and Social Support to Improve Diabetes Related Health Behavior for Inner-city Patients (NCT NCT01945996)

Results Overview

Number of patients lost to follow-up

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

3 months after enrollment

Results posted on

2018-11-06

Participant Flow

745 patients screened Excluded: * No mobile phone = 174 * Do not know how to text = 180 * HbA1c \<8 = 145 * No English or Spanish = 28 * Critically ill/AMS = 80 * Refused screening = 28

14 patients dropped before randomization * Unable to identify support person = 4 * Unable to contact support person = 22 * Support person can not text = 15

Participant milestones

Participant milestones
Measure	TExT-MED Only Patients will receive TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes) intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS Patients get TExT-MED intervention, supporter gets FANS curriculum (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes with Family And friends Network Supporters) TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Overall Study STARTED	22	22
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	TExT-MED Only Patients will receive TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes) intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS Patients get TExT-MED intervention, supporter gets FANS curriculum (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes with Family And friends Network Supporters) TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Overall Study Lost to Follow-up	3	5

Baseline Characteristics

Harnessing mHealth and Social Support to Improve Diabetes Related Health Behavior for Inner-city Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TExT-MED Only n=22 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=22 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges	Total n=44 Participants Total of all reporting groups
Age, Continuous	46.05 years STANDARD_DEVIATION 9.17 • n=5 Participants	46.04 years STANDARD_DEVIATION 9.86 • n=7 Participants	46.05 years STANDARD_DEVIATION 9.45 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Non-hispanic White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Latino	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Language Both Equally	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Language More English than Spanish	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Language More Spanish than English	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Language Only English	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Language Only Spanish	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after enrollment

Number of patients lost to follow-up

Outcome measures

Outcome measures
Measure	TExT-MED Only n=22 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=22 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Feasibility	3 Participants	5 Participants

PRIMARY outcome

Timeframe: 3 months after enrollment

Patient response to: I have enjoyed the TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) program?

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Acceptability Yes	18 Participants	17 Participants
Acceptability No	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 months follow up

Response to: Would you recommend TExT-MED FANS to family or friends?

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Acceptability 2: Would Patients Recommend the Program to Family or Friends? Yes	18 Participants	17 Participants
Acceptability 2: Would Patients Recommend the Program to Family or Friends? No	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months after enrollment

Population: Data was not collected as final program educational curriculum did not have sufficient overlap with Diabetes Knowledge Test Scale

Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months after enrollment

Change Diabetes Empowerment Scale - Short Form( measures feelings of self efficacy regarding diabetes disease management) from baseline to 6 month follow up scale minimum 8, maximum 40 Best possible change 40 (maximum at follow up) minus 8 (minimum at follow up)=32 Worst possible change: -32

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Change in Self-efficacy	.3 units on a scale Interval -0.1 to 0.7	0.1 units on a scale Interval -0.2 to 0.4

SECONDARY outcome

Timeframe: 3 months after enrollment

Change in Problem areas in diabetes scale (a measure of mental health problems that patient experience related to their diabetes) Baseline minus 3 month follow up. Higher score = more problems scale minimum 0 scale maximum 100 worst possible change -100 (0 problem scale at baseline, 100 at follow up) best possible change 100 (100 problem scale at baseline, 0 at follow up

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Change in Problem Areas in Diabetes Scale	-.9 units on a scale Interval -15.0 to 13.2	-6.8 units on a scale Interval -16.0 to -3.8

SECONDARY outcome

Timeframe: 3 months after enrollment

glycosylated hemoglobin A1c

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Glycemic Control	-0.6 % glycoslated hemoglobin Interval -1.4 to 0.2	-1.4 % glycoslated hemoglobin Interval -2.3 to -0.4

SECONDARY outcome

Timeframe: 3 months after enrollment

Population: Was not able to be collected

height and weight measurements

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months follow up

change in number of days patient followed a general diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Change in Summary of Diabetes Self-care Activities - General Diet Sub Score	0.1 units on a scale Interval -1.0 to 1.3	0.9 units on a scale Interval -0.3 to 2.0

SECONDARY outcome

Timeframe: 3 months follow up

change in number of days patient followed a diabetes specific diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score	0.9 units on a scale Interval -0.1 to 1.9	1.2 units on a scale Interval 0.2 to 2.0

SECONDARY outcome

Timeframe: 3 months follow up

change in number of days patient exercised (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Change in Summary of Diabetes Self-care Activities - Exercise Sub Score	0.7 units on a scale Interval -0.6 to 2.0	0.4 units on a scale Interval -0.6 to 1.3

SECONDARY outcome

Timeframe: 3 months follow up

change in number of days patient checked blood sugar (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score	-.7 units on a scale Interval -2.0 to 0.7	1.6 units on a scale Interval 0.5 to 2.7

SECONDARY outcome

Timeframe: 3 months follow up

change in number of days patient followed a foot care plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score	0.9 units on a scale Interval -0.3 to 2.1	1 units on a scale Interval -0.5 to 2.6

SECONDARY outcome

Timeframe: 3 months follow up

change in number of days patient followed a carb spacing plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)

Outcome measures

Outcome measures
Measure	TExT-MED Only n=19 Participants Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone	TExT-MED FANS n=17 Participants Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score	0.5 units on a scale Interval -0.6 to 1.5	0.5 units on a scale Interval -0.7 to 1.6

Adverse Events

TExT-MED Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TExT-MED FANS

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

Elizabeth Burner

University of Southern California

Phone: 3232266667

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place