ADS Plus Program for Caregiver Stress

(ADS Plus Trial)

No longer recruiting at 1 trial location

Overseen By Daniel Scerpella, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Terminal illness, Hospice, Others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called ADS Plus, designed to assist family caregivers of older adults with Alzheimer's or similar disorders. The goal is to determine if ADS Plus can enhance caregivers' well-being and reduce depression by offering support such as care management and stress reduction techniques. Participants will receive either the usual adult day services or those services with additional ADS Plus support. The trial seeks caregivers who are enrolling a relative in one of the participating adult day service sites and who have been actively involved in caregiving. As an unphased trial, this study provides caregivers with the opportunity to access innovative support strategies that could improve their caregiving experience.

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 focused on caregiver support rather than medication changes.

What prior data suggests that the ADS Plus program is safe for caregivers?

Research has shown that ADS Plus is generally well-received by caregivers. Studies examining its effects on caregiver well-being, stress, and depression have found positive results. However, specific information about side effects or negative reactions linked to ADS Plus remains limited. Since this program provides support services like counseling and education rather than medication, it is expected to carry a very low risk. The absence of reported negative reactions suggests that caregivers can participate with minimal concern about safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ADS Plus program because it offers a comprehensive approach to reducing caregiver stress that goes beyond typical support options. Unlike standard care, which might involve basic Adult Day Services, ADS Plus incorporates a personalized care plan that includes disease education, emotional support, and stress management techniques. This program stands out by providing consistent, face-to-face interactions with a care specialist, ensuring caregivers receive ongoing support tailored to their evolving needs. By addressing both the emotional and practical challenges caregivers face, ADS Plus aims to improve their overall well-being, making it a promising advancement in caregiver support.

What evidence suggests that the ADS Plus program is effective for caregiver stress?

Research shows that the ADS Plus program, which participants in this trial may receive, can help caregivers by reducing stress and feelings of depression. Studies have found that caregivers using ADS Plus feel less stressed and emotionally better. The program provides education about dementia and support for handling daily challenges. It also offers personalized care plans and regular check-ins to address new issues. These findings suggest that ADS Plus improves overall caregiver well-being. ^{2 3 6 7 8}

Who Is on the Research Team?

Laura Gitlin, PhD

Principal Investigator

Johns Hopkins University

Joseph Gaugler, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for caregivers over 21 years old who are starting to use Adult Day Services (ADS) for a relative with Alzheimer's or related disorders. They must speak English, have provided more than 8 hours of care in the past week, and be willing to do phone interviews. Caregivers planning to move or involved in other support services/trials can't join.

Inclusion Criteria

Caregivers have primary responsibility for care of the ADS client

Caregivers provided more than 8 hours of assistance to client in the past week

Caregivers have a telephone and are willing to participate in 4 telephone interviews (baseline, 3 month check-in; 6 and 12 month follow-ups)

Exclusion Criteria

Caregiver is involved in other caregiver support services/trials

Either I or my caregiver have been in the hospital more than 3 times last year.

I or my caregiver is currently receiving treatment for a terminal illness or is in hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline interviews and assessments are conducted to gather initial data on caregiver well-being and depressive symptoms

1 week

1 visit (in-person or virtual)

Intervention

Caregivers receive the ADS Plus intervention, which includes care management, referral/linkage, disease education, counseling/emotional support, and care skills training

12 months

Bi-weekly visits for the first 3 months, then monthly visits

Follow-up

Participants are monitored for long-term maintenance effects on caregiver well-being and depressive symptoms

12 months

3 visits (telephone interviews at 3, 6, and 12 months)

What Are the Treatments Tested in This Trial?

Interventions

• ADS Plus

Trial Overview The study tests 'ADS Plus,' an enhanced caregiver support program that includes care management, education about dementia, emotional support techniques, and skills training for managing behavioral symptoms. It aims to improve caregiver well-being and reduce depression at 6 months and assess long-term effects at 12 months.

How Is the Trial Designed?

Group I: ADS Plus Experimental Treatment 1 Intervention

Families in settings assigned to intervention will receive Adult Day Services (ADS) as usual in addition to ADS Plus. ADS Plus has 5 key components: care management, referral/linkage; disease education; counseling/emotional support/stress reduction, and care skills managing daily challenges and behavioral disturbances. The intervention begins with 2 face-to-face sessions with the site interventionist to conduct a needs assessment to identify concerns and needs and develop an agreed upon care plan. The interventionist then meets with caregivers face-to-face at convenient times to implement the care plan, every other week for the first 3 months, and then for monthly reassessments for newly emerging care concerns thereafter. Contact occurs about a minimum of 1 hour per month over 12 months.

Group II: ADS Usual Care Active Control 1 Intervention

Caregivers in the 15 sites assigned to serve as the usual care control group will receive Adult Day Services (ADS) as usual. Near completion of the study (project year 05), control group sites will have the option of receiving training in ADS Plus for their setting.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The study found that both educative and psychotherapeutic interventions effectively reduced caregiving strain, but the psychotherapeutic/support approach was the most effective over time, particularly at the 3-month follow-up.

Despite the effectiveness in reducing strain, neither intervention significantly impacted other stress-related symptoms like anxiety, somatization, or depression, indicating a need for targeted strategies for these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family caregiver stress: clinical assessment and management. Baldwin, BA., Kleeman, KM., Stevens, GL., et al.[2019]

The integrative stress reduction program (ISRP) significantly decreased caregiver stress and improved sleep quality, as measured by the Relative Stress Scale and Pittsburgh Sleep Quality Index, in a study involving 12 family caregivers over 4 weeks.

Care recipients also showed a reduction in behavioral and psychological symptoms of dementia (BPSD), indicating that the ISRP not only benefits caregivers but also positively impacts the well-being of those they care for.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrative Stress Reduction Program for Family Caregivers of Persons With Advanced Dementia: A Pilot Study. Sanprakhon, P., Chaimongkol, N., Hengudomsub, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12448453/

Fidelity matters: implementing ADS Plus, an evidence-based ... Caregiver outcomes. Two caregiver outcomes were considered: depressive symptoms and stress. For depressive symptoms, the 20-item Center for ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S155171441830689X

A multi-site randomized trial to test the Adult Day Service ... ADS Plus provides caregivers with disease education, referral/linkages, emotional support, self-care strategies, and skills to manage caregiver-identified ...

3. trialx.com trialx.com/clinical-trials/listings/256618/improving-outcome-for-family-caregivers-of-older-adults-with-complex-conditions-the-adult-day-plus-ads-plus-program/

Improving Outcome for Family Caregivers of Older Adults ... The purpose of the study is to: 1) evaluate the effectiveness of Adult Day Services (ADS) Plus to improve caregiver well-being and reduce ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753623/

Qualitative Analysis of Implementation Factors of an ... The present analysis utilizes data from the Improving Outcomes for Family Caregivers of Older Adults with Complex Conditions: The Adult Day Plus (ADS Plus) ...

5. jamda.com jamda.com/article/S1525-8610(23)00669-2/fulltext

Using Hybrid Effectiveness Studies to Facilitate ... The ADS Plus study featured several pragmatic elements: ADS sites identified candidate family caregivers from their census; study inclusion ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7069225/

Embedding caregiver support in community-based services ... ADS Plus provides caregivers with disease education, referral/linkages, emotional support, self-care strategies, and skills to manage caregiver-identified ...

7. withpower.com withpower.com/trial/phase-9-2016-398c0

ADS Plus Program for Caregiver Stress · Info for Participants The ADS Plus medical study, being run by Johns Hopkins University, needs participants to evaluate whether ADS Plus will have tolerable side effects ...

8. researchprotocols.org researchprotocols.org/2023/1/e49679/

The Senior Companion Program Plus for African American ... The outcome evaluation will include measures of caregivers' stress and burden, knowledge of ADRD, coping skills, social support and activity, ...