Caregiver-Patient Intervention for Type 2 Diabetes

Overseen By Aprill Dawson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Dementia, Substance abuse, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 11 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist older African Americans with poorly controlled type 2 diabetes by involving their caregivers in treatment. The study compares two groups: one receiving a special phone-based program called the Joint Home-DM-BAT Intervention, which includes diabetes education and support, and the other receiving regular diabetes information by mail. Researchers aim to determine if this approach improves health outcomes, such as blood sugar levels and quality of life, for both patients and their caregivers. It suits African Americans over 50 with type 2 diabetes who have a close friend or family member willing to support them for six months. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes care strategies and enhance community health.

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 prior data suggests that this intervention is safe for patients and caregivers?

Research has shown that the Joint Home-DM-BAT program is designed to be safe. This program offers education and support through phone calls. With no physical or medical procedures involved, it poses low risk to participants. As a behavioral and educational program, negative effects are unlikely. However, since this is a new approach, staying informed and asking questions about any concerns is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Joint Home-DM-BAT intervention because it offers a fresh approach to managing Type 2 diabetes by involving caregivers and addressing social needs alongside standard diabetes education. Unlike most diabetes treatments that focus solely on medication or dietary changes, this intervention includes interactive phone sessions with a trained health educator for personalized support and problem-solving. This approach not only aims to improve diabetes management but also enhances patient engagement and addresses the broader social factors that can impact health, potentially leading to more comprehensive and sustainable outcomes.

What evidence suggests that the Joint Home-DM-BAT intervention might be an effective treatment for type 2 diabetes?

Research has shown that involving both patients and their informal caregivers in diabetes care can help manage type 2 diabetes more effectively. In this trial, participants in the Joint Home-DM-BAT Intervention arm will receive a program designed to improve key health measures such as blood sugar levels (hemoglobin A1c), blood pressure, and cholesterol. Studies suggest that this approach, which includes diabetes education and problem-solving, can enhance the quality of life for both patients and caregivers. The program is delivered through phone sessions, making it accessible and supportive. Early findings indicate it could meet social needs and encourage healthier habits, which are crucial for effective diabetes management. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 identify as Black/African American.

I am 50 years old or older.

My type 2 diabetes is not well-controlled, with an HbA1c level of 8% or higher.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Joint Home-DM-BAT Intervention Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Involving family members in the management of type 2 diabetes is seen as crucial by healthcare professionals, highlighting the importance of creating a supportive environment for patients.

Successful implementation of innovations to enhance family involvement in patient education relies heavily on the commitment and support from healthcare professionals and management, as well as adaptability in group facilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Helms Andersen, T., Grabowski, D.[2020]

The couple-based collaborative management model (CCMM) for diabetes was developed through interviews and expert reviews, and it includes four key modules aimed at improving self-management among older Chinese adults with diabetes.

In a pilot study with 18 older couples, the CCMM showed good feasibility and acceptability, with positive trends in health outcomes and well-being, suggesting it may enhance diabetes management, although further research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of Couple-Based Collaborative Management Model of Type 2 Diabetes Mellitus for Community-Dwelling Chinese Older Adults: A Pilot Randomized Trial. Liu, Y., Xiao, X., Peng, C., et al.[2023]

A study involving 734 individuals with type 2 diabetes compared two self-management support programs: a standard program (CTH) and an enhanced version (EE-CTH) that included relationship-building strategies. Both programs led to significant improvements in self-management behaviors and psychological outcomes after 6 to 12 months.

The enhanced engagement program (EE-CTH) resulted in greater reductions in unhealthy food consumption, stress, and health-related distress, as well as improved depression symptoms compared to the standard program, highlighting the importance of addressing individual social challenges in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Hessler, D., Fisher, L., Dickinson, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining Variations in Action Plan Quality Among Adults With Type 2 Diabetes in Primary Care. Kjaer, PH., Fisher, L., Potter, MB., et al.[2021]

In a study of 115 elderly patients with type 2 diabetes, increased physical exercise was linked to lower hemoglobin A1c levels, indicating better blood sugar control.

Patients whose caregivers had higher education levels and those living with partners showed significantly better diabetes management, suggesting that support systems play a crucial role in treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the behavior of elderly type 2 diabetic patients and their relatives as caregivers on diabetes follow-up parameters in Bolu, Turkey. Gucuk, S.[2016]

The review of 10 studies on family interventions for adults with Type 1 and Type 2 diabetes found that while these interventions are important, they often focus more on disease knowledge and lifestyle changes rather than on family dynamics.

There is a lack of consistency in the design and outcomes of these interventions, making it challenging to determine effective approaches; however, incorporating psychosocial and family dimensions could enhance the effectiveness of family-based diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lost in translation--the role of family in interventions among adults with diabetes: a systematic review. Torenholt, R., Schwennesen, N., Willaing, I.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A mixed-methods study involving 53 adults with type 2 diabetes revealed that while many participants experienced both supportive and obstructive family behaviors, only 48% lived with their primary source of diabetes support, highlighting the complexity of family dynamics in diabetes management.

Despite the challenges, 40% of participants believed that involving family members in diabetes interventions could have a positive impact, suggesting that targeted family engagement strategies could enhance self-care and glycemic control, especially among low-income and racial/ethnic minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family behaviors and type 2 diabetes: What to target and how to address in interventions for adults with low socioeconomic status. Mayberry, LS., Harper, KJ., Osborn, CY.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological family intervention for poorly controlled type 2 diabetes. Keogh, KM., Smith, SM., White, P., et al.[2022]

Educational interventions for healthcare professionals, including a 6-hour standardized course, significantly improved their attitudes and motivation towards monitoring diabetes, which is crucial for patient safety.

The study suggests that these interventions can enhance the control of diabetes in patients, as measured by HbA1c levels, although the specific outcomes on patient control were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. Cabré, JJ., Ripoll, M., Hernández, JM., et al.[2021]

A 4-month telephonic couples behavioral intervention significantly improved A1C levels and obesity measures in adults with type 2 diabetes, showing that collaboration in managing diabetes can be effective.

While all intervention groups (couples calls, individual calls, and diabetes education) led to A1C reductions, the couples intervention particularly benefited those with moderate A1C levels and showed advantages in psychosocial outcomes, suggesting the importance of support in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health and Psychosocial Outcomes of a Telephonic Couples Behavior Change Intervention in Patients With Poorly Controlled Type 2 Diabetes: A Randomized Clinical Trial. Trief, PM., Fisher, L., Sandberg, J., et al.[2022]

In a study of 81 patients with type 2 diabetes, only 36% achieved adequate glycemic control, defined as HbA1c levels below 6.5%.

Higher levels of family support were linked to better glycemic control, with patients receiving medium support having three times the risk of uncontrolled blood glucose compared to those with high family support, while knowledge about diabetes did not significantly impact glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Association of family support and knowledge about the disease with glycemic control in diabetic patients]. Ávila-Jiménez, L., Cerón O, D., Ramos-Hernández, RI., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/14EACF0B4B8AC6D57598B8961CAA4A01A2FFCEB861BF/project-details/10644727

Joint Patient and Caregiver Intervention for Older African ... The proposed study will test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06279637

Joint Patient and Caregiver Intervention for Older African ... This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem ...

3. trialx.com trialx.com/clinical-trials/listings/322397/joint-patient-and-caregiver-intervention-for-older-african-americans-with-type-2-diabetes/

Joint Patient and Caregiver Intervention for Older African ... 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) ...

4. withpower.com withpower.com/trial/caregiver-patient-intervention-for-type-2-diabetes-f8077

Caregiver-Patient Intervention for Type 2 Diabetes This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05744-1

HOME DM-BAT: home-based diabetes-modified behavioral ... Results from this study will provide important insight into the effectiveness of a home-based diabetes-modified behavioral activation treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8574935/

HOME DM-BAT: home-based diabetes-modified behavioral ... This is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34749788/

HOME DM-BAT: home-based diabetes-modified behavioral ... This is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment ...