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Completed

NCT Number: NCT02481596

FAMS Mobile Health Intervention for Diabetes Self-care Support

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federally Qualified Health Centers & Vanderbilt Primary Care Clinics

Nashville, Tennessee, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

*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)

Treatment and study plan

REACH + FAMS

Behavioral

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.

Other names: Family-focused intervention

REACH

Behavioral

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).

Other names: NCT02409329

Helpline & A1c results

Behavioral

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.

Primary outcomes

  1. Adherence to Diet - Use of Dietary Information

    Time frame: 3 months, 6 months

    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)

  2. Adherence to Exercise

    Time frame: 3 months, 6 months

    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. Adherence to Diet - Problem Eating Behavior

    Time frame: 3 months, 6 months

    as measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse)

Secondary outcomes

  1. Supportive Family Behaviors

    Time frame: 3 months, 6 months

    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)

  2. Obstructive Family Behaviors

    Time frame: 3 months, 6 months

    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. Diabetes Self-efficacy

    Time frame: 3 months, 6 months

    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)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2015
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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