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
1 other identifier
interventional
512
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started May 2016
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedStudy Start
First participant enrolled
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedResults Posted
Study results publicly available
November 27, 2019
CompletedNovember 27, 2019
November 1, 2019
2.1 years
June 23, 2015
July 19, 2019
November 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Supportive Family Behaviors
3 months, 6 months
Obstructive Family Behaviors
3 months, 6 months
Diabetes Self-efficacy
3 months, 6 months
Study Arms (3)
REACH + FAMS
EXPERIMENTALParticipants 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.
REACH
EXPERIMENTALParticipants 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.
Helpline & A1c results
ACTIVE 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.
Interventions
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.
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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)
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federally Qualified Health Centers & Vanderbilt Primary Care Clinics
Nashville, Tennessee, United States
Related Publications (3)
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.
PMID: 27891524BACKGROUNDNelson 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.
PMID: 29636319BACKGROUNDMayberry 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.
PMID: 32706852DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lindsay S. Mayberry, PhD, MS
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lindsay S Mayberry, MS, PhD
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The outcomes assessor for the primary outcome for the larger trial (NCT02409329) was blinded, but outcomes assessors for these outcomes were not.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 23, 2015
First Posted
June 25, 2015
Study Start
May 23, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
November 27, 2019
Results First Posted
November 27, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 6 months after final trial results publication. No end date.
- Access Criteria
- Approval of a proposal by the study PI.
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.