Clinical trial NCT04347291: Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
Official title: Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: family support
social support
text message
mobile health
hemoglobin A1c
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-04-15
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycemic Control (Patient Participants) During Intervention Period
timeFrame: Baseline and 6 and 9 months post-baseline
measure: Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects
timeFrame: Baseline and 12 and 15 months post-baseline
measure: Change in Diabetes Distress (Patient Participants) During Intervention Period
timeFrame: Baseline and 6 and 9 months post-baseline
measure: Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect
timeFrame: Baseline and 15 months post-baseline
measure: Change in Psychosocial Well-being (Patient Participants) During Intervention Period
timeFrame: Baseline and 6 and 9 months post-baseline
measure: Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect
timeFrame: Baseline and15 months post-baseline
Secondary outcomes:
measure: Change in Diabetes Distress (Support Person Participants) During Intervention Period
timeFrame: Baseline and 6 and 9 months post-baseline
measure: Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect
timeFrame: Baseline and 15 months post-baseline
measure: Change in Support Burden (Support Person Participants) During Intervention Period
timeFrame: Baseline and 6 and 9 months post-baseline
measure: Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect
timeFrame: Baseline and 15 months post-baseline
Other outcomes:
measure: Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6 and 9 months post-baseline
measure: Change in Dietary Behavior (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Dietary Behavior (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Physical Activity (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
measure: Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator)
timeFrame: Baseline and 6, 9, and 15 months post-baseline
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: Mayberry LS, El-Rifai M, Nelson LA, Parks M, Greevy RA Jr, LeStourgeon L, Molli S, Bergner E, Spieker A, Aikens JE, Wolever RQ. Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons. Contemp Clin Trials. 2022 Nov;122:106956. doi: 10.1016/j.cct.2022.106956. Epub 2022 Oct 5.