ADS Plus Program for Caregiver Stress

(ADS Plus Trial)

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

208 Participants Needed

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 focused on caregiver support rather than medication changes.

What data supports the effectiveness of the ADS Plus treatment for caregiver stress?

The ADS Plus program, which includes adult day services, has been shown to improve caregivers' daily mood by reducing stress from dealing with dementia symptoms. Additionally, similar stress reduction programs have been effective in decreasing caregiver stress and improving sleep quality. ^{1 2 3 4 5}

Is the ADS Plus Program safe for caregivers?

The ADS Plus Program, which includes adult day services, has been studied for its effects on stress and well-being in caregivers. While the research primarily focuses on stress reduction and emotional benefits, there are no reports of harmful effects, suggesting it is generally safe for caregivers. ^{1 3 6 7 8}

How is the ADS Plus treatment different from other treatments for caregiver stress?

ADS Plus is unique because it integrates caregiver support directly into adult day services, providing a structured program that enhances caregiver well-being and reduces stress by increasing service use and potentially delaying nursing home placement for those they care for. ^{3 6 7 9 10}

What is the purpose of this trial?

Over 15 million family caregivers provide more than 85% of long-term care to older adults with Alzheimer's Disease and Related Disorders. Caregivers typically assume care responsibilities without training or support and may in turn experience multiple health risks including depression. Providing evidence-based caregiver supportive programs on a wide scale basis is identified by the National Alzheimer's Plan Act as a national priority. One approach is to augment existing community-based services for older adults with a caregiver evidence-based program. Adult day service (ADS) is one such growing and critical community-based option for older adults with Alzheimer's Disease and related disorders but which does not systematically address common caregiver challenges or burdens using evidence-based programs. The purpose of the study is to: 1) evaluate the effectiveness of Adult Day Services (ADS) Plus to improve caregiver well-being and reduce depressive symptoms compared to routine ADS use at 6 months; and 2) evaluate long-term maintenance effects of ADS Plus at 12 months on caregiver well-being and depressive symptoms. ADS Plus consists of 5 key components: care management, referral/linkage, education about dementia, situational counseling/emotional support/stress reduction techniques, and skills to manage behavioral symptoms (e.g., rejection of care, agitation, aggression). Based on care challenges identified by family caregivers, an "ADS Plus Prescription" is provided, a written document detailing easy-to-use strategies to address specified care challenges and caregivers are trained in their use. The proposed study will employ a practical trial design to assess the effectiveness and uptake of ADS Plus on a large scale. Thirty ADS programs throughout the U.S. varying in geographic location and staffing levels will be involved. A total of 300 diverse caregivers (150 in 15 ADS Plus sites; 150 in 15 ADS usual care sites) will be enrolled.

Research Team

Laura Gitlin, PhD

Principal Investigator

Johns Hopkins University

Joseph Gaugler, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

I plan to use the ADS device for at least 1 week over 6 months.

Caregivers have primary responsibility for care of the ADS client

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

Exclusion Criteria

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

Caregiver is involved in other caregiver support services/trials

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Adult day services and dementia caregivers' daily affect: the role of distress response to behavioral and psychological symptoms of dementia. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The PLUS intervention: a pilot test with caregivers of depressed older adults. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Enhancing quality of life of families who use adult day services: Short- and long-term effects of the adult day services plus program. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An Integrative Stress Reduction Program for Family Caregivers of Persons With Advanced Dementia: A Pilot Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Family caregiver stress: clinical assessment and management. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Anticipating an Easier Day: Effects of Adult Day Services on Daily Cortisol and Stress. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Modeling Cortisol Daily Rhythms of Family Caregivers of Individuals With Dementia: Daily Stressors and Adult Day Services Use. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of adult day care on daily stress of caregivers: a within-person approach. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Embedding Caregiver Support within Adult Day Services: Outcomes of a Multi-site Trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A stress-busting program for family caregivers. [2019]