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Enrolling by Invitation

NCT Number: NCT07210593

STrong Relationships to Improve DiabEtes Pilot

This is a pilot and feasibility study for a mobile phone-delivered intervention, called STRIDE (STrong Relationships to Improve DiabEtes), designed to provide support for adults with type 2 diabetes (improve glycemic management and social support). The goal of the study is to examine the feasibility and acceptability of STRIDE.

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

PERSONS WITH DIABETES:

  • 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
  • Elevated diabetes distress or low diabetes self-efficacy
  • Willing to invite a close friend or family member to co-participate

SUPPORT PERSONS:

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

Exclusion criteria

PERSONS WITH DIABETES

  • Unable to communicate by phone
  • Currently pregnant
  • 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
  • Demonstrated an inability to receive and respond to a text
  • Does not take medication on his/her own/medication administered by someone else SUPPORT PERSONS
  • Demonstrated inability to receive & respond to a text
  • Unable to communicate by phone

Treatment and study plan

FAMS

Behavioral

PWD participants will receive FAMS components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment.

Co-enrolled SP participants will receive high-quality print materials upon enrollment and receive text message support tailored to the goal set by the linked PWD.

PEER

Behavioral

PWD participants will receive PEER components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment PWD participants assigned to PEER will be matched with another PWD participant assigned to peer to provide peer support to each other.

Primary outcomes

  1. Acceptability

    Time frame: 6 months post-baseline

    Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score >0) indicate good acceptability

  2. Feasibility (Recruitment)

    Time frame: baseline

    Number of participants screened/week

  3. Feasibility (Recruitment)

    Time frame: baseline

    Proportion of eligible screens who enroll

  4. Feasibility (Treatment Adherence)

    Time frame: 6 months post-baseline

    Proportion of sessions attended

  5. Feasibility (Treatment Adherence)

    Time frame: 6 months post-baseline

    Proportion of interactive texts with response

  6. Feasibility (Assessment Completion)

    Time frame: 3 and 6 months post-baseline

    Proportion of self-report measures completed

Secondary outcomes

  1. Change in Hemoglobin A1c

    Time frame: Baseline and 3 and 6 months post-baseline

    Hemoglobin A1c assessed by mail-in A1c kits from BioQuintex and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management

  2. Change in Diabetes Distress

    Time frame: Baseline and 3 and 6 months post-baseline

    Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse)

  3. Change in Psychosocial Well-being

    Time frame: Baseline and 3 and 6 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)

  4. Change in Social Support for Diabetes

    Time frame: Baseline and 3 and 6 months post-baseline

    Assessed by the Diabetes Support Scale (DSS) with scores ranging 12 to 84 where higher scores indicate more social support for diabetes (better)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

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

Registry information

Official study title

STrong Relationships to Improve DiabEtes (STRIDE) Pilot

Acronym: STRIDE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 7, 2025
Registry last updated
Oct 20, 2025

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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