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Completed

NCT Number: NCT04347291

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

FAMS 2.0

Behavioral

FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled.

Other names: Family/friend Activation to Motivate Self-care, (prior iteration) Family-focused Add-on to Motivate Self-care (NCT02481596)

print materials

Behavioral

Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.

Primary outcomes

  1. Change in Glycemic Control (Patient Participants) During Intervention Period

    Time frame: 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

  2. Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects

    Time frame: 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

  3. Change in Diabetes Distress (Patient Participants) During Intervention Period

    Time frame: 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)

  4. Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect

    Time frame: 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)

  5. Change in Psychosocial Well-being (Patient Participants) During Intervention Period

    Time frame: 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)

  6. Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect

    Time frame: 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 outcomes

  1. Change in Diabetes Distress (Support Person Participants) During Intervention Period

    Time frame: 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)

  2. Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect

    Time frame: 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)

  3. Change in Support Burden (Support Person Participants) During Intervention Period

    Time frame: 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)

  4. Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect

    Time frame: 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)

Other outcomes

  1. Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6 and 9 months post-baseline

    as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better)

  2. Change in Dietary Behavior (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by Personal Diabetes Questionnaire, Use of Information for Decision Making Scale with scores ranging 1-6 where higher scores indicate more use of dietary information for decision making (better)

  3. Change in Dietary Behavior (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by Personal Diabetes Questionnaire, Problem Eating Behavior scale with scores ranging 1-6 where higher scores indicate more problem eating behaviors (worse)

  4. Change in Physical Activity (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by a modified Rapid Assessment of Physical Activity with scores ranging 0 to 6533 with higher scores indicating more physical activity (better)

  5. Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by the Summary of Diabetes Self-Care Activities medications subscale with scores ranging 0 to 7 representing days in the prior week with perfect adherence (higher better)

  6. Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by the Adherence to Refills and Medications in Diabetes scale, with scores ranging 11-44 with higher scores indicating more problems with adherence (worse)

  7. Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more helpful involvement (better)

  8. Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by the Important Others Climate Questionnaire, specific to diabetes management, with scores ranging 1 to 5 with higher scores indicating more autonomy supportive communication (better)

  9. Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse)

  10. Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by the criticism items from the Family Emotional Involvement and Criticism Scale, specific to diabetes management, with scores ranging 0 to 16 with higher scores indicating more perceived criticism (worse)

  11. Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more helpful involvement (better)

  12. Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse)

  13. Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator)

    Time frame: Baseline and 6, 9, and 15 months post-baseline

    as assessed by items from the Family Experience of Patient Involvement measure from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where a score of 2 indicates alignment between the support person's current level of involvement and their desired level of involvement. We will report change in the % aligned (reporting a 2) across conditions.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: FAMS 2

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2020
Registry last updated
Jan 17, 2024

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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