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Enrolling by invitation NCT07210593

STrong Relationships to Improve DiabEtes Pilot

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FAMS, PEER.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

STrong Relationships to Improve DiabEtes (STRIDE) Pilot

Overview

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.

Interventions

  • Behavioral FAMS
    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.
  • Behavioral PEER
    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 outcome measures

  • Acceptability [Time frame: 6 months post-baseline]
  • Feasibility (Recruitment) [Time frame: baseline]
  • Feasibility (Recruitment) [Time frame: baseline]
  • Feasibility (Treatment Adherence) [Time frame: 6 months post-baseline]
  • Feasibility (Treatment Adherence) [Time frame: 6 months post-baseline]
  • Feasibility (Assessment Completion) [Time frame: 3 and 6 months post-baseline]
Secondary outcome measures (4)
  • Change in Hemoglobin A1c [Time frame: Baseline and 3 and 6 months post-baseline]
  • Change in Diabetes Distress [Time frame: Baseline and 3 and 6 months post-baseline]
  • Change in Psychosocial Well-being [Time frame: Baseline and 3 and 6 months post-baseline]
  • Change in Social Support for Diabetes [Time frame: Baseline and 3 and 6 months post-baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT07210593 · 250845 · K23DK140531

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗