100 Participants Needed

Caregiver-Patient Intervention for Type 2 Diabetes

AZ
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Overseen ByAprill Dawson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education and support rather than medication changes.

What data supports the effectiveness of the Joint Home-DM-BAT treatment for Type 2 Diabetes?

Research shows that family support and psychological interventions can help improve blood sugar control in people with type 2 diabetes. Additionally, programs that enhance self-management and involve patient engagement have been found to improve diabetes outcomes, suggesting that involving caregivers in diabetes management could be beneficial.12345

Is the Caregiver-Patient Intervention for Type 2 Diabetes safe for humans?

The available research does not provide specific safety data for the Caregiver-Patient Intervention for Type 2 Diabetes or its related names. However, the studies focus on improving diabetes management and self-care, which suggests that the interventions are generally aimed at supporting health rather than posing safety risks.45678

How is the Joint Home-DM-BAT treatment for Type 2 Diabetes different from other treatments?

The Joint Home-DM-BAT treatment is unique because it involves both the patient and their caregiver in managing Type 2 Diabetes, focusing on family involvement to create a supportive environment, which is not typically emphasized in standard diabetes treatments.59101112

What is the purpose of this trial?

This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.The aims of the study are:Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden.

Eligibility Criteria

This trial is for older African Americans (50+) with poorly controlled type 2 diabetes (HbA1c ≥8%). Participants must self-identify as Black/African American, speak English, and have a caregiver willing to join the study. Caregivers should be ready to support the patient for six months and attend four one-hour sessions.

Inclusion Criteria

I am 50 years old or older.
I identify as Black/African American.
My type 2 diabetes is not well-controlled, with an HbA1c level of 8% or higher.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Joint Home-DM-BAT intervention with 8 weekly sessions and 3 monthly booster sessions via telephone

11 weeks
8 weekly sessions (telephone), 3 monthly booster sessions (telephone)

Follow-up

Participants are monitored for changes in clinical outcomes such as hemoglobin A1c, blood pressure, and LDL-Cholesterol

6 months

Treatment Details

Interventions

  • Joint Home-DM-BAT Intervention
Trial Overview The trial tests a telephone-delivered intervention that includes diabetes education, problem-solving, and behavioral activation against usual care. It aims to improve clinical outcomes like blood sugar control, blood pressure, cholesterol levels, and quality of life for patients and caregivers.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Joint Home-DM-BAT InterventionExperimental Treatment1 Intervention
A trained health educator will deliver the manualized Joint Home-DM-BAT intervention. Participants will receive 8-weekly sessions of diabetes education, problem solving around social needs, and behavioral activation via telephone; and 3 monthly booster sessions.
Group II: Usual CareActive Control1 Intervention
Patients randomized to the usual care arm will receive weekly mailings of diabetes education modules for 8 weeks and monthly mailings for 3 months to match the weekly and monthly booster sessions.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Findings from Research

The study identified key conditions for effective couple-based collaborative management (CCMM) of type 2 diabetes in older Chinese couples, emphasizing the importance of spousal willingness and correct beliefs about diabetes management for improving glycated hemoglobin (HbA1c) control.
Barriers to CCMM included strong autonomy among patients, particularly husbands, and low literacy levels leading to misconceptions about diabetes management, highlighting the need for tailored interventions that consider couples' preferences and understanding.
Conditions for successful implementation of couple-based collaborative management model of diabetes among community-dwelling older Chinese: a qualitative comparative analysis.Zhang, J., Yang, C., Liu, Y., et al.[2023]
In a study involving 725 type 2 diabetes patients across 12 primary care sites, the overall quality of action plans for self-management was rated as moderate to high, with a mean score of 14.62 out of 20.
Higher health literacy and the absence of social risks were linked to better action plan quality, which in turn increased patient confidence in their management plans, highlighting the importance of tailoring support to individual patient needs.
Examining Variations in Action Plan Quality Among Adults With Type 2 Diabetes in Primary Care.Kjaer, PH., Fisher, L., Potter, MB., et al.[2021]
A family-based psychological intervention significantly reduced A1C levels in patients with poorly controlled type 2 diabetes, with the intervention group showing an average A1C of 8.4% compared to 8.8% in the control group after 6 months.
The intervention was particularly effective for patients with the highest baseline A1C levels (over 9.5%), leading to notable improvements in diabetes-related beliefs, psychological well-being, diet, exercise, and family support.
Psychological family intervention for poorly controlled type 2 diabetes.Keogh, KM., Smith, SM., White, P., et al.[2022]

References

Conditions for successful implementation of couple-based collaborative management model of diabetes among community-dwelling older Chinese: a qualitative comparative analysis. [2023]
Examining Variations in Action Plan Quality Among Adults With Type 2 Diabetes in Primary Care. [2021]
Psychological family intervention for poorly controlled type 2 diabetes. [2022]
[Association of family support and knowledge about the disease with glycemic control in diabetic patients]. [2022]
The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. [2022]
Health and Psychosocial Outcomes of a Telephonic Couples Behavior Change Intervention in Patients With Poorly Controlled Type 2 Diabetes: A Randomized Clinical Trial. [2022]
Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. [2021]
Family behaviors and type 2 diabetes: What to target and how to address in interventions for adults with low socioeconomic status. [2022]
Implementing a research-based innovation to generate intra-familial involvement in type 2 diabetes self-management for use in diverse municipal settings: a qualitative study of barriers and facilitators. [2020]
Development and Implementation of Couple-Based Collaborative Management Model of Type 2 Diabetes Mellitus for Community-Dwelling Chinese Older Adults: A Pilot Randomized Trial. [2023]
Effects of the behavior of elderly type 2 diabetic patients and their relatives as caregivers on diabetes follow-up parameters in Bolu, Turkey. [2016]
Lost in translation--the role of family in interventions among adults with diabetes: a systematic review. [2018]
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