STrong Relationships to Improve DiabEtes Pilot

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT07210593
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study Start: 2025-10-01
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Acceptability	6 months post-baseline	Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score \>0) indicate good acceptability
Feasibility (Recruitment)	baseline	Proportion of eligible screens who enroll
Feasibility (Treatment Adherence)	6 months post-baseline	Proportion of interactive texts with response
Feasibility (Assessment Completion)	3 and 6 months post-baseline	Proportion of self-report measures completed

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	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
Change in Diabetes Distress	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)
Change in Psychosocial Well-being	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)
Change in Social Support for Diabetes	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)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States