FAMS Mobile Health Intervention for Diabetes Self-care Support

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: REACH + FAMS
* Behavioral: REACH
* Behavioral: Helpline & A1c results


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REACH + FAMS<br>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<br>* 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.<br>* Other names: Family-focused intervention;Behavioral: REACH<br>* 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).<br>* Other names: NCT02409329;Behavioral: Helpline & A1c results<br>* 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.<br>|
| Experimental: REACH<br>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<br>* 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).<br>* Other names: NCT02409329;Behavioral: Helpline & A1c results<br>* 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.<br>|
| Active Comparator: Helpline & A1c results<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
family, support, diet, exercise, social