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FAMS 2.0 for Type 2 Diabetes (FAMS 2 Trial)

N/A
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6, 9, and 15 months post-baseline
Awards & highlights

FAMS 2 Trial Summary

This trial evaluates a mobile phone intervention designed to help adults with type 2 diabetes set and achieve self-care goals, and improve the quality of family/friend support for their goals. The investigators hypothesize that the intervention will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons.

Eligible Conditions
  • Type 2 Diabetes

FAMS 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6, 9, and 15 months post-baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6, 9, and 15 months post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Diabetes Distress (Patient Participants) During Intervention Period
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect
Change in Glycemic Control (Patient Participants) During Intervention Period
+3 more
Secondary outcome measures
Change in Diabetes Distress (Support Person Participants) During Intervention Period
Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect
Change in Support Burden (Support Person Participants) During Intervention Period
+1 more
Other outcome measures
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator)
Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator)
Change in Dietary Behavior (Patient Participants - Outcome & Mediator)
+6 more

FAMS 2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FAMS 2.0Experimental Treatment2 Interventions
Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.
Group II: Print MaterialsPlacebo Group1 Intervention
All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Print Materials
2020
N/A
~780
FAMS 2.0
2020
N/A
~640

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
671,555 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,313,954 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the latest version of FAMS been sanctioned by the FDA?

"While there is data that supports the safety of FAMS 2.0, there isn't any evidence to suggest it has an effective application yet, so our team at Power assigned a score of 2 on a 1-3 scale."

Answered by AI

Are there still vacancies to join this trial?

"Clinicaltrials.gov states that this trial is not presently recruiting patients, despite having initially been posted on April 28th 2020 and most recently edited on November 28th 2022. Fortunately, there are 1284 other studies currently enrolling volunteers from the public."

Answered by AI

What are the principal aims of this clinical investigation?

"The primary objective of this investigation, which will be evaluated during a baseline visit and again 6 and 9 months later, is to assess the long-term psychosocial well-being of patients. Secondary goals include quantifying any changes in support burden (as measured by DAWN2) for family members, as well as diabetes distress experienced by those same loved ones both during intervention period and beyond. Each metric is scored from 0 to 100 - with higher scores denoting increased levels of stress or strain."

Answered by AI

Is the minimum age requirement for this trial higher than 20 years?

"The qualifications for this medical trial are individuals aged between 18 and 75. Those under the age of 18 can choose from 188 different studies, while 964 trials accept participants over 65 years old."

Answered by AI

Who can participate in this medical experiment?

"This clinical trial is recruiting 334 individuals with type 2 diabetes mellitus, aged 18-75. Crucially, they must possess the following qualifications: Be literate in English, Have a positive diagnosis of type 2 diabetes, Receive treatment from an affiliated clinic or hospital, Live independently (i.e., not in long term care), Take at least one daily medication for diabetes management, Own a mobile phone and be over 18 years old."

Answered by AI
~130 spots leftby Apr 2025