Diabetes Mellitus, Type 2NCT02409329

Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

A study testing REACH, Helpline and A1c results and REACH + FAMS in people with Diabetes Mellitus, Type 2, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: REACH, Helpline and A1c results and REACH + FAMS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 512 participants
Where: 1 siteUnited States
Study dates: 23 May 2016to 4 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged 18 years and older
Individuals who have received a diagnosis for type 2 diabetes mellitus
Enrolled as a patient at a participating community health center
Individuals currently being treated with oral and/or injectable diabetes medications

Who cannot join

Non-English speakers
Individuals who report they do not have a cell phone
Individuals unwilling and/or not able to provide written informed consent
Individuals with unintelligible speech (e.g., dysarthria)
Individuals with a severe hearing or visual impairment
Individuals who report a caregiver administers their diabetes medications Individuals who fail the cognitive screener administered during the baseline survey
Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant
Individuals whose most recent (within 12 months) HbA1c value was 6.8% or greater

Trial locations and contacts

1 site in 1 country.

United States1 site

Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
Nashville, Tennessee, 37203

Other trials in United States

About this study

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.

Conditions: Diabetes Mellitus, Type 2
Being tested: REACH, Helpline and A1c results, REACH + FAMS
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

REACHBehavioural
The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c resultsBehavioural
Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
REACH + FAMSBehavioural
Also called NCT02481596
The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging.

Study groups in NCT02409329
Study group	Role	What they receive
REACH	Experimental	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Receives: Behavioral: REACH; Behavioral: Helpline and A1c results
REACH + FAMS	Experimental	In addition to the REACH text messages tailored to user's individual barriers to adherence, 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. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Receives: Behavioral: Helpline and A1c results; Behavioral: REACH + FAMS
Helpline and A1c results	Active comparator	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, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Receives: Behavioral: Helpline and A1c results

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful
Measured: Baseline, 3 months, 6 months, 12 months, 15 months

Secondary outcomes (2)

Change in Self-reported Medication Adherence
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
Measured: Baseline, 3 months, 6 months, 12 months, 15 months
Change in Self-reported Medication Adherence
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
Measured: Baseline, 3 months, 6 months, 12 months, 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 20164 Jun 2019

First posted6 Apr 2015 (estimated)
Study start23 May 2016
Primary completion4 Jun 2019
Study completion4 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 512 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02409329
Sponsor's protocol ID: 140562
Other IDs: 1R01DK100694-01A1
Status last verified: Aug 2020
First submitted: 9 Mar 2015
Last updated: 17 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data collected during the trial will be de-identified and made available following publication of the 15-month trial results to researchers who provide a methodologically sound proposal.

Publications

Nelson LA, Mayberry LS, Wallston K, Kripalani S, Bergner EM, Osborn CY. Development and Usability of REACH: A Tailored Theory-Based Text Messaging Intervention for Disadvantaged Adults With Type 2 Diabetes. JMIR Hum Factors. 2016 Sep 8;3(2):e23. doi: 10.2196/humanfactors.6029.
PubMed 27609738
Nelson LA, Wallston KA, Kripalani S, Greevy RA Jr, Elasy TA, Bergner EM, Gentry CK, Mayberry LS. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 10;7(4):e92. doi: 10.2196/resprot.9443.
PubMed 29636319
Roddy MK, Mayberry LS, Nair D, Cavanaugh KL. Exploring mHealth potential to improve kidney function: secondary analysis of a randomized trial of diabetes self-care in diverse adults. BMC Nephrol. 2022 Aug 10;23(1):280. doi: 10.1186/s12882-022-02885-6.
PubMed 35948873
Mayberry LS, Bergner EM, Harper KJ, Laing S, Berg CA. Text messaging to engage friends/family in diabetes self-management support: acceptability and potential to address disparities. J Am Med Inform Assoc. 2019 Oct 1;26(10):1099-1108. doi: 10.1093/jamia/ocz091.
PubMed 31403688

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02409329
Acronym / sponsor ID: 140562
Conditions: Diabetes Mellitus, Type 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 512 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 23 May 2016 (actual)
Primary completion: 4 Jun 2019 (actual)
Study completion: 4 Jun 2019 (actual)
First posted: 6 Apr 2015 (estimated)
Results: Posted 17 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
REACH	Experimental	Behavioral: REACH, Behavioral: Helpline and A1c resultsParticipants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH + FAMS	Experimental	Behavioral: Helpline and A1c results, Behavioral: REACH + FAMSIn addition to the REACH text messages tailored to user's individual barriers to adherence, 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. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results	Active comparator	Behavioral: Helpline and A1c resultsParticipants 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, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults aged 18 years and older
Individuals who have received a diagnosis for type 2 diabetes mellitus
Enrolled as a patient at a participating community health center
Individuals currently being treated with oral and/or injectable diabetes medications

Key exclusion criteria (8 listed)

Non-English speakers
Individuals who report they do not have a cell phone
Individuals unwilling and/or not able to provide written informed consent
Individuals with unintelligible speech (e.g., dysarthria)
Individuals with a severe hearing or visual impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REACHThe intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.	Behavioural	REACH
Helpline and A1c resultsParticipants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	Behavioural	Helpline and A1c results, REACH, REACH + FAMS
REACH + FAMSAlso: NCT02481596The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging.	Behavioural	REACH + FAMS

Primary outcome

Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
Time frame: 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

2 secondary outcomes

Change in Self-reported Medication Adherence
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months
Change in Self-reported Medication Adherence
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months

Results and safety

Results posted to the registry on 17 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
REACH	127	122
REACH + FAMS	126	120
Helpline and A1c Results	253	244

Primary outcome: Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)

Time frame: Baseline, 3 months, 6 months, 12 months, 15 months. Mean (Standard Deviation). Unit: percent

Measure	REACH n = 253	Helpline and A1c Results n = 253
3 months	8.29 (1.49)	8.59 (1.65)
6 months	8.32 (1.65)	8.57 (2.15)
12 months	8.66 (1.97)	8.70 (2.10)
15 months	8.59 (1.81)	8.61 (1.95)

REACH vs Helpline and A1c Results: Predicted mean difference: -0.313 (95% CI -0.610 to -0.017), p = .0493, GEE, Wald test
REACH vs Helpline and A1c Results: Predicted mean difference: -0.070 (95% CI -0.380 to 0.240), p = 0.260, GEE, Wald test

Population analysed: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: We followed participants for 15 months of study participation, lasting from recruitment start May 2016 until the last participant completed 15-month follow-up in June 2019.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
REACH	0 of 127 (0%)	0 of 127 (0%)	3 of 127
REACH + FAMS	0 of 126 (0%)	0 of 126 (0%)	2 of 126
Helpline and A1c Results	0 of 253 (0%)	0 of 253 (0%)	3 of 253

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27609738Nelson LA, Mayberry LS, Wallston K, Kripalani S, Bergner EM, Osborn CY. Development and Usability of REACH: A Tailored Theory-Based Text Messaging Intervention for Disadvantaged Adults With Type 2 Diabetes. JMIR Hum Factors. 2016 Sep 8;3(2):e23. doi: 10.2196/humanfactors.6029.
Background: PubMed 29636319Nelson LA, Wallston KA, Kripalani S, Greevy RA Jr, Elasy TA, Bergner EM, Gentry CK, Mayberry LS. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 10;7(4):e92. doi: 10.2196/resprot.9443.
Derived from this study: PubMed 35948873Roddy MK, Mayberry LS, Nair D, Cavanaugh KL. Exploring mHealth potential to improve kidney function: secondary analysis of a randomized trial of diabetes self-care in diverse adults. BMC Nephrol. 2022 Aug 10;23(1):280. doi: 10.1186/s12882-022-02885-6.
Derived from this study: PubMed 31403688Mayberry LS, Bergner EM, Harper KJ, Laing S, Berg CA. Text messaging to engage friends/family in diabetes self-management support: acceptability and potential to address disparities. J Am Med Inform Assoc. 2019 Oct 1;26(10):1099-1108. doi: 10.1093/jamia/ocz091.
Individual participant dataSharing planned: Yes. Individual participant data collected during the trial will be de-identified and made available following publication of the 15-month trial results to researchers who provide a methodologically sound proposal.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lindsay S Mayberry, MS, PhD principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing REACH, Helpline and A1c results and REACH + FAMS in people with Diabetes Mellitus, Type 2, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) (time frame: Baseline, 3 months, 6 months, 12 months, 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02409329, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.