Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
180 participants
INTERVENTIONAL
2025-10-15
2027-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
NCT04347291
Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes
NCT05691452
FAMS Mobile Health Intervention for Diabetes Self-care Support
NCT02481596
Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
NCT02409329
A Randomized Trial of an Intensive Education Intervention Using a Network of Involved Diabetic Patients (Peer Educators) to Improve Glycemic Control of Type 2 Diabetic Patients
NCT01485913
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Step 1: Optimal First Line Treatment
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.
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.
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.
Experimental: Step 2: Optimal Second Line Treatment
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
McKenzie Roddy
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
250845
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.