FAMS Mobile Health Intervention for Diabetes Self-care Support

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481596
• Other study ID #: 140562_A
• Status: Completed
• Phase: N/A
• Start date: May 23, 2016
• Est. completion date: July 2018

Study information

• Verified date: November 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

*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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	Federally Qualified Health Centers & Vanderbilt Primary Care Clinics	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2016 Nov 7. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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