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Family-Focused Diabetes Management for Type 2 Diabetes

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individual with type 2 diabetes aged 40 years or older

Individual with type 2 diabetes having A1c > 7.5% at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (t1) to six months after intervention (t3) at month 11

Awards & highlights

Study Summary

This trial tests a family-focused intervention to help African Americans with type 2 diabetes improve their quality of life and glycemic control.

Who is the study for?

African American adults over 40 with type 2 diabetes and a family member (spouse, adult child, or sibling) who live together can join. Both must speak English and be able to walk. The patient needs an A1c > 7.5% and diagnosed for at least six months. Those with cognitive impairments, advanced conditions, or unclear diabetes diagnosis are excluded.Check my eligibility

What is being tested?

The trial is testing how well a program designed for African American adults with type 2 diabetes and their family members works in improving blood sugar control and quality of life. It's a randomized controlled study comparing the new intervention against usual care.See study design

What are the potential side effects?

Since this is not a drug trial but an educational intervention focusing on self-management of diabetes within families, there may not be direct side effects like those seen with medication; however, participants might experience stress or time constraints.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 or older with type 2 diabetes.

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My A1c level is above 7.5% and I have type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (t1) to six months after intervention (t3) at month 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (t1) to six months after intervention (t3) at month 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t1) to six months after intervention (t3) at month 11 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 control

Change in health-related quality of life

Secondary outcome measures

Change in blood pressure control

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Patient-family member dyads in the family dyad intervention arm will receive 1) 14 sessions (8 weekly and 6 biweekly) over 20 weeks of family-dyad-focused, in-person group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.

Group II: ControlActive Control1 Intervention

All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,412 Total Patients Enrolled

Media Library

Family dyad diabetes intervention Clinical Trial Eligibility Overview. Trial Name: NCT05905575 — N/A

Type 2 Diabetes Research Study Groups: Control, Intervention

Type 2 Diabetes Clinical Trial 2023: Family dyad diabetes intervention Highlights & Side Effects. Trial Name: NCT05905575 — N/A

Family dyad diabetes intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05905575 — N/A

Frequently Asked Questions

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

What criteria must be met for someone to qualify as a participant in this clinical study?

"Those aged between 40 and 90 years old can participate in this medical trial, provided they have been diagnosed with type 2 diabetes. At present, there are 208 total participants being sought after."

Answered by AI

Does this trial cater to participants aged fifty-five and over?

"This clinical trial requires applicants to be between 40 and 90 years old. Conversely, there are 193 studies available for children under 18 and 1,092 trials open to the elderly over 65."

Answered by AI

Is this research project actively looking for new participants?

"Upon reviewing the information found on clinicaltrials.gov, it appears that this trial is not presently seeking participants. This study was initially posted on June 12th 2023 and its records were last updated 6 days later. Although no recruitment is taking place at present, there are 1412 other trials currently accepting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults

2023. "A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05905575.