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Diabetes Mellitus, Type 2NCT02481596

FAMS Mobile Health Intervention for Diabetes Self-care Support

A study testing REACH + FAMS, REACH and Helpline & A1c results 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

This study evaluates a family-focused mobile phone-delivered intervention, called FAMS (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes in their self-management relative to a control group. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
REACH + FAMS, REACH and Helpline & A1c results
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 Jul 2018
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
  • Healthy volunteers accepted
  • 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
Show all 18Show fewer
  • 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
  • Support persons invited to receive text messages must meet following criteria:
  • Support Person Inclusion Criteria:
  • Adults aged 18 years and older
  • Identified by the patient as a part of their family (can be related biologically or legally, or be a close friend/roommate who participates in the patients' daily routine)
  • Support Person Exclusion Criteria:
  • Non-English speakers (determined subjectively by a trained research assistant)
  • 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) (determined subjectively by a trained research assistant)
  • Individuals with a severe hearing or visual impairment (determined subjectively by a trained research assistant)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Federally Qualified Health Centers & Vanderbilt Primary Care Clinics

    Nashville, Tennessee

Other trials in United States

About this study

Official title: Family-Focused Mobile Health Intervention: Targeting Family Behaviors to Improve Type 2 Diabetes Management Among Adults

This study evaluates a family-focused mobile phone-delivered intervention, called FAMS (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to ascertain if family-focused content delivered to the patient can improve the patients' family support for diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations.

Read the detailed description

Family members perform diabetes-specific behaviors that are helpful and/or harmful to the adult managing type 2 diabetes. Family behaviors are strongly associated with patients' adherence to diet and exercise: supportive family behaviors with more adherence and harmful family behaviors with less adherence. This six-month intervention seeks to increase supportive and reduce harmful family behaviors, and to improve diabetes-related self-efficacy and adherence to diet and exercise recommendations among adult patients with content that can be delivered via basic mobile phones (i.e., phone calls and text messages).

FAMS components include:

  • Six 20-30 minute coaching sessions with patient participants by phone focusing on helpful/unhelpful/desired family behaviors relevant to the patients' self-identified daily diet or exercise goal (occurs after enrollment and monthly for six months)
  • Text messages to the patient to support him/her in meeting the identified daily goal (4 per week)
  • The option to invite an adult support person to receive text messages (3 per week) encouraging the support person to discuss the patient's self-care goal to provide opportunities for the patient to practice skills discussed during phone coaching

This intervention evaluation is nested within a larger randomized controlled trial (RCT; see NCT02409329) which evaluates REACH, a text messaging intervention to improve participants' adherence to self-care and glycemic control. We will evaluate these interventions with a three arm trial. Participants will be randomized to receive REACH only, REACH+FAMS, or an active control. Participants assigned to REACH+FAMS will receive the above described components for the first six months of the trial, and then REACH only until the end of the trial. Analyses will examine outcomes of FAMS at 3 and 6 months.

Being tested
REACH + FAMS, REACH, Helpline & A1c results
Keywords
family, support, diet, exercise, social
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity

What participants receive

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

  • REACH + FAMSBehavioural

    Also called Family-focused intervention

    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.

  • REACHBehavioural

    Also called NCT02409329

    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 resultsBehavioural

    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.

Study groups in NCT02481596
Study groupRoleWhat they receive
REACH + FAMSExperimentalParticipants 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.
Receives: Behavioral: REACH + FAMS; Behavioral: REACH; Behavioral: Helpline & A1c results
REACHExperimentalParticipants 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.
Receives: Behavioral: REACH; Behavioral: Helpline & A1c results
Helpline & A1c resultsActive comparatorParticipants 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.
Receives: Behavioral: Helpline & A1c results

What is being measured

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

  1. Adherence to Diet - Use of Dietary Information

    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)

    Measured: 3 months, 6 months

  2. Adherence to Exercise

    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

    Measured: 3 months, 6 months

  3. Adherence to Diet - Problem Eating Behavior

    as measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse)

    Measured: 3 months, 6 months

Secondary outcomes (3)

  1. Supportive Family Behaviors

    as 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)

    Measured: 3 months, 6 months

  2. Obstructive Family Behaviors

    as 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)

    Measured: 3 months, 6 months

  3. Diabetes Self-efficacy

    as 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)

    Measured: 3 months, 6 months

Timeline

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

  1. First posted25 Jun 2015 (estimated)
  2. Study start23 May 2016
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

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
None (open label)
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02481596
Sponsor's protocol ID
140562_A
Status last verified
Nov 2019
First submitted
23 Jun 2015
Last updated
27 Nov 2019
Data monitoring committee
Yes
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 (see NCT02409329) to researchers who provide a methodologically sound proposal.

Publications

  • Mayberry LS, Berg CA, Harper KJ, Osborn CY. The Design, Usability, and Feasibility of a Family-Focused Diabetes Self-Care Support mHealth Intervention for Diverse, Low-Income Adults with Type 2 Diabetes. J Diabetes Res. 2016;2016:7586385. doi: 10.1155/2016/7586385. Epub 2016 Nov 7.

    PubMed 27891524

  • 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

  • Mayberry LS, Berg CA, Greevy RA, Nelson LA, Bergner EM, Wallston KA, Harper KJ, Elasy TA. Mixed-Methods Randomized Evaluation of FAMS: A Mobile Phone-Delivered Intervention to Improve Family/Friend Involvement in Adults' Type 2 Diabetes Self-Care. Ann Behav Med. 2021 Mar 16;55(2):165-178. doi: 10.1093/abm/kaaa041.

    PubMed 32706852

Questions about this trial

What is this clinical trial studying?

A study testing REACH + FAMS, REACH and Helpline & A1c results 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 18 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 27 Nov 2019. 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 27 Nov 2019). 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?

Adherence to Diet - Use of Dietary Information (time frame: 3 months, 6 months). The study lists 3 primary outcomes in all. 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 NCT02481596, which also lists 3 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 27 Nov 2019.

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