STrong Relationships to Improve DiabEtes Pilot
STRIDE
2 other identifiers
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2025
CompletedFirst Posted
Study publicly available on registry
October 7, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
October 20, 2025
October 1, 2025
1.3 years
September 29, 2025
October 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Acceptability
Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score \>0) indicate good acceptability
6 months post-baseline
Feasibility (Recruitment)
Number of participants screened/week
baseline
Feasibility (Recruitment)
Proportion of eligible screens who enroll
baseline
Feasibility (Treatment Adherence)
Proportion of sessions attended
6 months post-baseline
Feasibility (Treatment Adherence)
Proportion of interactive texts with response
6 months post-baseline
Feasibility (Assessment Completion)
Proportion of self-report measures completed
3 and 6 months post-baseline
Secondary Outcomes (4)
Change in Hemoglobin A1c
Baseline and 3 and 6 months post-baseline
Change in Diabetes Distress
Baseline and 3 and 6 months post-baseline
Change in Psychosocial Well-being
Baseline and 3 and 6 months post-baseline
Change in Social Support for Diabetes
Baseline and 3 and 6 months post-baseline
Study Arms (2)
Experimental: Step 1: Optimal First Line Treatment
EXPERIMENTALPersons with diabetes (PWD) participants will first be randomized to an optimal first line treatment in order to compare FAMS vs. PEER. PWD participants assigned to Step 1 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD. PWD participants assigned to Step 1 treatment "PEER" will be paired with another participant to provide each other peer support.
Experimental: Step 2: Optimal Second Line Treatment
EXPERIMENTALAll PWD participants will be randomized at month 3 to FAMS or PEER. PWD participants assigned to Step 2 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD if not previously enrolled. PWD participants assigned to Step 2 treatment "PEER" will be paired with another participant to provide each other peer support. If they had previously enrolled a SP, the SP participant will stop receiving text messages.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- PERSONS WITH DIABETES:
- 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
- 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
- years or older
- Owns a mobile phone
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 29, 2025
First Posted
October 7, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- After study results are posted on clinical trials (required to occur within 1 year of final data collection), scientific data will be submitted to the Open Science Framework (OSF). Under the current repository policies, data will be preserved and available for the wider research community in perpetuity.
- Access Criteria
- Survey, clinical, and laboratory data and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be shared and made publicly available through OSF as open access. Survey, clinical, and laboratory data will be made available in csv and text format and will not require the use of specialized tools to be accessed or manipulated. All shared data and documentation will be findable and identifiable using the standard data indexing tools in Open Science Framework.
After study results are posted on clinical trials, de-identified individual and aggregate survey, clinical, and laboratory data (including raw and recoded data) and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be made publicly available through the Open Science Framework (OSF).