STrong Relationships to Improve DiabEtes Pilot (STRIDE)

Vanderbilt University Medical Center

Status: Invitation-only

Conditions: Type 2 Diabetes

Treatments: Behavioral: FAMS; Behavioral: PEER

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07210593

250845

K23DK140531 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Experimental: Step 1: Optimal First Line Treatment

Experimental group

Description:

Persons 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.

Treatment:

Behavioral: PEER

Behavioral: FAMS

Experimental: Step 2: Optimal Second Line Treatment

Experimental group

Description:

All 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.

Treatment:

Behavioral: PEER

Behavioral: FAMS