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FAMS Mobile Health Intervention for Diabetes Self-care Support

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ClinicalTrials.gov Identifier: NCT02481596
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Lindsay Mayberry, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: REACH + FAMS Behavioral: REACH Behavioral: Helpline & A1c results Not Applicable

Detailed Description:

Family members perform diabetes-specific behaviors that are harmful and/or helpful 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  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Family-Focused Mobile Health Intervention: Targeting Family Behaviors to Improve Type 2 Diabetes Management Among Adults
Actual Study Start Date : May 23, 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: REACH + FAMS

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
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 Name: Family-focused intervention

Behavioral: 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).
Other Name: NCT02409329

Behavioral: Helpline & A1c results
Participants have 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.

Experimental: REACH

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
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 Name: NCT02409329

Behavioral: Helpline & A1c results
Participants have 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.

Active Comparator: Helpline & A1c results

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
Participants have 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 Outcome Measures :
  1. Change in adherence to diet relative to control group [ Time Frame: baseline, 3 months, 6 months ]
    as measured by Personal Diabetes Questionnaire diet subscales

  2. Change in adherence to exercise relative to control group [ Time Frame: baseline, 3 months, 6 months ]
    as measured by International Physical Activity Questionnaire


Secondary Outcome Measures :
  1. Change in supportive family behaviors relative to the control group [ Time Frame: baseline, 3 months, 6 months ]
    as measured by scores on patient-report measure

  2. Change in obstructive family behaviors relative to the control group [ Time Frame: baseline, 3 months, 6 months ]
    as measured by scores on patient-report measure

  3. Change in diabetes-related self-efficacy relative to the control group [ Time Frame: baseline, 3 months, 6 months ]
    as measured by scores on the Perceived Diabetes Self-Management Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481596


Locations
United States, Tennessee
Federally Qualified Health Centers & Vanderbilt Primary Care Clinics
Nashville, Tennessee, United States
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Lindsay S Mayberry, MS, PhD Vanderbilt University Medical Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lindsay Mayberry, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02481596     History of Changes
Other Study ID Numbers: 140562_A
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lindsay Mayberry, Vanderbilt University Medical Center:
family
support
diet
exercise
social

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases