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

NCT04347291 | Completed Results DMC

• 2 other identifiers: 200398R01DK119282
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

family support; social support; text message; mobile health; hemoglobin A1c

Outcome Measures

Primary Outcomes (6)

• Change in Glycemic Control (Patient Participants) During Intervention Period

  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

  Baseline and 6 and 9 months post-baseline

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

  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

  Baseline and 12 and 15 months post-baseline

• Change in Diabetes Distress (Patient Participants) During Intervention Period

  Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)

  Baseline and 6 and 9 months post-baseline

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

  Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)

  Baseline and 15 months post-baseline

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

  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)

  Baseline and 6 and 9 months post-baseline

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

  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)

  Baseline and15 months post-baseline

Secondary Outcomes (4)

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

  Baseline and 6 and 9 months post-baseline

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

  Baseline and 15 months post-baseline

• Change in Support Burden (Support Person Participants) During Intervention Period

  Baseline and 6 and 9 months post-baseline

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

  Baseline and 15 months post-baseline

Other Outcomes (13)

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

  Baseline and 6 and 9 months post-baseline

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

  Baseline and 6, 9, and 15 months post-baseline

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

  Baseline and 6, 9, and 15 months post-baseline

Study Arms (2)

FAMS 2.0

EXPERIMENTAL

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.

Behavioral: FAMS 2.0; Behavioral: Print Materials

Print Materials

PLACEBO COMPARATOR

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.

Behavioral: Print Materials

Interventions

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.

Also known as: Family/friend Activation to Motivate Self-care, (prior iteration) Family-focused Add-on to Motivate Self-care (NCT02481596)

FAMS 2.0

Print Materials BEHAVIORAL

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

FAMS 2.0; Print Materials

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (3)

• Roddy MK, Spieker AJ, Greevy RA Jr, Nelson LA, Berg C, Mayberry LS. Diabetes-specific family functioning typology associated with intervention engagement and effects: secondary analyses from a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae070. doi: 10.1093/abm/kaae070.

  PMID: 39661957 DERIVED

• Roddy MK, El-Rifai M, LeStourgeon L, Aikens JE, Wolever RQ, Greevy RA, Mayberry LS. Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant. Chronic Illn. 2025 Mar;21(1):105-114. doi: 10.1177/17423953231203734. Epub 2023 Sep 26.

  PMID: 37750180 DERIVED

• 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.

  PMID: 36208719 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Lindsay Mayberry
• Organization: Vanderbilt University Medical Center

lindsay.mayberry@vumc.org

615-875-5821

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators use mail-in A1c kits for the primary outcome - hemoglobin A1c - and the lab analyzing these samples is masked to study description or participants' assigned condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 15, 2020
• Study Start: April 28, 2020
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: January 17, 2024
• Results First Posted: January 17, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
• Access Criteria: Contact the principal investigator

Locations

US (1)