NCT02409329

Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

Completed NA Results posted Last updated 17 August 2020

What this trial tests

NA trial testing REACH in Diabetes Mellitus, Type 2 in 512 participants. Completed in 4 June 2019.

Timeline

23 May 2016

Primary endpoint
4 June 2019

4 June 2019

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	512
Start date	23 May 2016
Primary completion	4 June 2019
Estimated completion	4 June 2019
Sites	1 location across United States

Drugs / interventions tested

• REACH
• Helpline and A1c results
• REACH + FAMS

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) Primary · Baseline, 3 months, 6 months, 12 months, 15 months

as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful

3 months

Group	Value	95% CI
REACH	8.29	± 1.49
Helpline and A1c Results	8.59	± 1.65

6 months

Group	Value	95% CI
REACH	8.32	± 1.65
Helpline and A1c Results	8.57	± 2.15

12 months

Group	Value	95% CI
REACH	8.66	± 1.97
Helpline and A1c Results	8.70	± 2.10

15 months

Group	Value	95% CI
REACH	8.59	± 1.81
Helpline and A1c Results	8.61	± 1.95

Change in Self-reported Medication Adherence Secondary · Baseline, 3 months, 6 months, 12 months, 15 months

as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence

3 months

Group	Value	95% CI
REACH	6.59	± 0.96
Helpline and A1c Results	6.38	± 1.25

6 months

Group	Value	95% CI
REACH	6.64	± 0.89
Helpline and A1c Results	6.24	± 1.51

12 months

Group	Value	95% CI
REACH	6.50	± 1.09
Helpline and A1c Results	6.27	± 1.46

15 months

Group	Value	95% CI
REACH	6.36	± 1.22
Helpline and A1c Results	6.18	± 1.45

Change in Self-reported Medication Adherence Secondary · Baseline, 3 months, 6 months, 12 months, 15 months

as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44

3 months

Group	Value	95% CI
REACH	40.4	± 3.62
Helpline and A1c Results	40.4	± 3.45

6 months

Group	Value	95% CI
REACH	40.6	± 3.48
Helpline and A1c Results	40.2	± 3.49

12 months

Group	Value	95% CI
REACH	40.3	± 3.48
Helpline and A1c Results	40.2	± 3.99

15 months

Group	Value	95% CI
REACH	40.5	± 3.24
Helpline and A1c Results	40.4	± 3.90

Change in Adherence to Dietary Behavior Secondary · Baseline, 3 months, 6 months, 12 months, 15 months

as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better)

3 months

Group	Value	95% CI
REACH	3.17	± 1.59
Helpline and A1c Results	2.84	± 1.58

6 months

Group	Value	95% CI
REACH	3.34	± 1.56
Helpline and A1c Results	2.93	± 1.62

12 months

Group	Value	95% CI
REACH	3.22	± 1.58
Helpline and A1c Results	2.88	± 1.61

15 months

Group	Value	95% CI
REACH	3.17	± 1.65
Helpline and A1c Results	3.01	± 1.77

Change in Adherence to Dietary Behavior Secondary · Baseline, 3 months, 6 months, 12 months, 15 months

Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)

3 months

Group	Value	95% CI
REACH	3.17	± 1.03
Helpline and A1c Results	3.28	± 1.13

6 months

Group	Value	95% CI
REACH	3.11	± 0.95
Helpline and A1c Results	3.18	± 1.06

12 months

Group	Value	95% CI
REACH	3.09	± 1.07
Helpline and A1c Results	3.13	± 1.09

15 months

Group	Value	95% CI
REACH	3.18	± 1.15
Helpline and A1c Results	3.18	± 1.11

Change in Physical Activity Secondary · Baseline, 3 months, 6 months, 12 months, 15 months

as 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

3 months

Group	Value	95% CI
REACH	2285	± 2973
Helpline and A1c Results	2139	± 2501

6 months

Group	Value	95% CI
REACH	2332	± 3168
Helpline and A1c Results	1991	± 2547

12 months

Group	Value	95% CI
REACH	2573	± 3329
Helpline and A1c Results	2273	± 2883

15 months

Group	Value	95% CI
REACH	2221	± 2973
Helpline and A1c Results	2239	± 2774

Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control Secondary · Baseline, 3 months, 6 months, 12 months, 15 months

as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.

3 months

Group	Value	95% CI
REACH	9.12	± 1.41
REACH + FAMS	8.98	± 1.61
Helpline and A1c Results	9.47	± 1.77

6 months

Group	Value	95% CI
REACH	8.88	± 1.64
REACH + FAMS	9.14	± 1.53
Helpline and A1c Results	9.74	± 2.37

12 months

Group	Value	95% CI
REACH	9.45	± 1.89
REACH + FAMS	9.57	± 2.19
Helpline and A1c Results	9.67	± 2.21

15 months

Group	Value	95% CI
REACH	9.28	± 1.97
REACH + FAMS	9.41	± 1.74
Helpline and A1c Results	9.57	± 2.25

Sponsor's own description

This study evaluates a mobile phone-delivered intervention, called REACH (Rapid Education/Encouragement And Communications for Health), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to determine if individually tailored content (based on the Information-Motivation-Behavioral Skills Model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications. We will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial.
   Nelson LA, Greevy RA, Spieker A, Wallston KA, et al · · 2021 · cited 50× · PMID 33154039 · DOI 10.2337/dc20-0961
2. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial.
   Nelson LA, Wallston KA, Kripalani S, Greevy RA, et al · · 2018 · cited 28× · PMID 29636319 · DOI 10.2196/resprot.9443
3. Text messaging to engage friends/family in diabetes self-management support: acceptability and potential to address disparities.
   Mayberry LS, Bergner EM, Harper KJ, Laing S, et al · · 2019 · cited 13× · PMID 31403688 · DOI 10.1093/jamia/ocz091
4. Retaining diverse adults with diabetes in a long-term trial: Strategies, successes, and lessons learned.
   Nelson LA, Williamson SE, LeStourgeon LM, Mayberry LS. · · 2021 · cited 4× · PMID 33812991 · DOI 10.1016/j.cct.2021.106388
5. Exploring mHealth potential to improve kidney function: secondary analysis of a randomized trial of diabetes self-care in diverse adults.
   Roddy MK, Mayberry LS, Nair D, Cavanaugh KL. · · 2022 · cited 2× · PMID 35948873 · DOI 10.1186/s12882-022-02885-6