Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes (FAMS 2)

Vanderbilt University Medical Center

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Print Materials; Behavioral: FAMS 2.0

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04347291

200398

R01DK119282 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 638 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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638 participants in 2 patient groups, including a placebo group

FAMS 2.0

Experimental group

Description:

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.

Treatment:

Behavioral: Print Materials

Behavioral: FAMS 2.0

Print Materials

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Print Materials