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Family vs. Individual Diabetes Education for Diabetes
N/A
Waitlist Available
Led By Ann-Marie Rosland, MD,MS
Research Sponsored by University of Pittsburgh
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 vs. 12 months
Awards & highlights
Study Summary
This trial will compare two different approaches to managing diabetes - one that involves support from family and friends, and one that is focused on individual patients.
Who is the study for?
This trial is for adults over 21 with Type 2 diabetes and a recent HbA1c level of at least 7.5%. Participants must plan to use the recruiting site's healthcare services for a year and have a family member or friend involved in their care. It excludes those with gestational diabetes, severe mental health conditions, life-limiting illnesses, pregnancy plans within a year, or non-English/Spanish speakers.Check my eligibility
What is being tested?
The study compares two programs: FAM-ACT (Family Support for Health Action) which involves family in diabetes management, against I-DSMES (individual patient-focused education/support). The goal is to see which one better helps manage diabetes.See study design
What are the potential side effects?
Since this trial focuses on educational support rather than medication, there are no direct medical side effects. However, participants may experience stress or time constraints due to the commitment required by the program sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline vs. 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs. 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in patient glycemic control at 6 months
Secondary outcome measures
Change from baseline in patient glycemic control at 12 months
Change in diabetes distress in patient
Change in systolic blood pressure
Other outcome measures
Change in diabetes distress in support person
Change in diabetes self-care behaviors in patient: Healthy Eating
Change in diabetes self-care behaviors in patient: Medication Adherence
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FAM-ACTExperimental Treatment1 Intervention
Patient and Support Person (dyad) will be included together as much as possible. The dyad will:
Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile.
Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each.
Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes.
Group II: I-DSMESActive Control1 Intervention
This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will:
Take part in a one-hour introductory session and review of patient's diabetes management risk assessment.
Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each.
Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FAM ACT
2019
N/A
~450
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,341,897 Total Patients Enrolled
19 Trials studying Diabetes
108,620 Patients Enrolled for Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,314,742 Total Patients Enrolled
107 Trials studying Diabetes
138,663 Patients Enrolled for Diabetes
The Community Health and Social Services Center, Inc.OTHER
1 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with schizophrenia or another psychotic disorder.You were diagnosed with diabetes before you turned 21 years old.You have been diagnosed with a serious mental illness like schizophrenia.Your most recent HbA1c test in the past 3 months is 7.5% or higher.You must be at least 21 years old.You have been diagnosed with gestational diabetes, but not with any other type of diabetes.You have been diagnosed with Alzheimer's disease or dementia, either currently or in the past.You have been diagnosed with Type 2 diabetes.You have a serious illness that limits your life, such as needing oxygen for chronic obstructive pulmonary disease.
Research Study Groups:
This trial has the following groups:- Group 1: FAM-ACT
- Group 2: I-DSMES
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is my profile compatible with the criteria for this experiment?
"This medical trial is seeking 536 volunteers who have diabetes mellitus and are aged 21 - 75. The prerequisites for candidacy include holding a Type 2 diabetes diagnosis, having an HbA1c done in the last three months prior to screening that surpasses 7.5%, being committed to using the recruiting site as their health care provider over the next year, nominating one family member or friend to be involved with their healthcare journey and possessing agency over their own bodily decisions."
Answered by AI
Is this experiment still recruiting volunteers?
"This study, which was first made available on September 23rd 2019 and last modified November 18th 2022, is still recruiting patients according to clinicaltrials.gov."
Answered by AI
How many individuals are being enrolled in this scientific experiment?
"Affirmative. According to the clinicaltrials.gov page for this study, it is actively recruiting and accepting new participants since its initial posting on September 23rd of 2019. 536 patients are sought from two medical facilities."
Answered by AI
Are individuals of a younger age range admissible for this research?
"This research initiative is looking to enlist individuals aged between 21 and 75."
Answered by AI
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