Clinical trial NCT02481596: FAMS Mobile Health Intervention for Diabetes Self-care Support
Official title: Family-Focused Mobile Health Intervention: Targeting Family Behaviors to Improve Type 2 Diabetes Management Among Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: family
support
diet
exercise
social
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: \*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)

Primary outcomes:
measure: Adherence to Diet - Use of Dietary Information
timeFrame: 3 months, 6 months
measure: Adherence to Exercise
timeFrame: 3 months, 6 months
measure: Adherence to Diet - Problem Eating Behavior
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Supportive Family Behaviors
timeFrame: 3 months, 6 months
measure: Obstructive Family Behaviors
timeFrame: 3 months, 6 months
measure: Diabetes Self-efficacy
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Federally Qualified Health Centers & Vanderbilt Primary Care Clinics
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lindsay S Mayberry, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.