FAMS Mobile Health Intervention for Diabetes Self-care Support

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: REACH + FAMS; Behavioral: REACH; Behavioral: Helpline & A1c results

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.

• Study Type: Interventional
• Enrollment (Actual): 512
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States
      • Federally Qualified Health Centers & Vanderbilt Primary Care Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

*Note: Criteria for patient participants is consistent with larger study (NCT02409329).

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Family-focused intervention; Behavioral: 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).; Other Names: NCT02409329; Behavioral: 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.
Experimental: 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.	Behavioral: 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).; Other Names: NCT02409329; Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months, 6 months
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	3 months, 6 months
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)	3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months, 6 months
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)	3 months, 6 months
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)	3 months, 6 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Lindsay S Mayberry, MS, PhD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: exercise; family; diet; social; support
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 140562_A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after final trial results publication. No end date.
• IPD Sharing Access Criteria: Approval of a proposal by the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL