Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: FAMS 2.0; Behavioral: Print Materials

• Registration Number: NCT04347291
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.

Detailed Description

The 9-month FAMS 2.0 intervention is an expansion and improvement of a previously evaluated intervention (FAMS; NCT02481596). FAMS components include:

* Monthly coaching sessions (20-30 minutes each) with patient participants by phone focusing on helpful/unhelpful/desired family and friend behaviors relevant to the patients' self-identified diet, exercise, and/or stress management goal

* Daily one-way and interactive text messages to the patient to support him/her in meeting the identified daily goal and medication adherence

* Weekly interactive text messages asking the patient to reflect on goal progress followed by personalized feedback from the coach

* The option to invite an adult support person to receive text messages (3 one-way per week and one interactive text 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

Participants will be randomized in a parallel design to either FAMS 2.0 or an active control. Our target enrollment is N=334 dyads (patient participants and support persons). Patients are encouraged to invite a support person, but it is not required. Patients and their support person will be randomized together (if enrolled). The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects at 9 months (post-intervention) and 15 months (sustained effects). The investigators will impute missing data, including all participants completing at least two data collection periods in analyses. Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-15
• Study Start: 2020-04-28
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-17
• Results First Submitted: 2023-11-27
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Results First Posted: 2024-01-17
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 638

Inclusion Criteria

PATIENTS:

• Speaks and reads in English
• 18-75 years old
• Diagnosed with type 2 diabetes
• Receiving outpatient care from a partnering clinic
• Community dwelling (e.g., not in a nursing facility)
• Prescribed at least one daily diabetes medication
• Owns a mobile phone

SUPPORT PERSONS:

• Speaks and reads in English
• 18 years or older
• Owns a mobile phone

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Exclusion Criteria

PATIENTS:

• Unable to communicate by phone
• Pregnant currently
• Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
• Diagnosed with end-stage renal disease
• Receiving hospice services
• Diagnosed with congestive heart failure
• Diagnosed with dementia
• Diagnosed with schizophrenia
• Reported current abuse during screening
• Demonstrates inability to receive and respond to a text
• Does not take medication on his/her own/medication administered by someone else

SUPPORT PERSONS:

• Demonstrates inability to receive and respond to a text

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FAMS 2.0	FAMS 2.0	Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.
FAMS 2.0	Print Materials	Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.
Print Materials	Print Materials	All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.

Primary Outcome Measures

Name	Time	Method
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects	Baseline and 12 and 15 months post-baseline	Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control
Change in Diabetes Distress (Patient Participants) During Intervention Period	Baseline and 6 and 9 months post-baseline	Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect	Baseline and 15 months post-baseline	Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)
Change in Glycemic Control (Patient Participants) During Intervention Period	Baseline and 6 and 9 months post-baseline	Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control
Change in Psychosocial Well-being (Patient Participants) During Intervention Period	Baseline and 6 and 9 months post-baseline	Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)
Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect	Baseline and15 months post-baseline	Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)

Secondary Outcome Measures

Name	Time	Method
Change in Diabetes Distress (Support Person Participants) During Intervention Period	Baseline and 6 and 9 months post-baseline	as assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 where higher scores indicate more diabetes distress experienced by the support person (worse)
Change in Support Burden (Support Person Participants) During Intervention Period	Baseline and 6 and 9 months post-baseline	as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where higher scores indicate greater support burden (worse)
Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect	Baseline and 15 months post-baseline	Assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 with higher scores indicate more diabetes distress experienced by the support person (worse)
Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect	Baseline and 15 months post-baseline	as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 100 where higher scores indicate greater support burden (worse)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States