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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
512
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.
Federally Qualified Health Centers & Vanderbilt Primary Care Clinics
Nashville, Tennessee, United States
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)
Time frame: 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
Time frame: 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)
Time frame: 3 months, 6 months
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)
Time frame: 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)
Time frame: 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)
Time frame: 3 months, 6 months
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