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ADS Plus Program for Caregiver Stress (ADS Plus Trial)

N/A

Waitlist Available

Led By Laura Gitlin, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Either caregiver or client has been hospitalized more than 3 times in the past year

Either caregiver or client is in active treatment for a terminal illness or are in hospice

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the effectiveness of a program called ADS Plus, which is designed to help caregivers of people with Alzheimer's Disease. The program includes components like education about dementia and skills to manage behavioral symptoms. The trial will involve 300 caregivers from across the United States.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since ADS Plus involves non-medical interventions like education and counseling rather than drugs or medical procedures, it does not have typical side effects. However, participants may experience varying levels of stress relief or emotional changes.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decrease Depressive Symptoms in Caregivers as assessed by Center for Epidemiological Studies Depression Scale (CES-D).

Improve Caregiver Well-being as assessed by the Perceived Change Scale

Secondary study objectives

Cost Analysis of Intervention as assessed by the Resource Utilization in Dementia (RUD)

Cost Analysis of Intervention as assessed by the Service Utilization and Resources Survey (SURF)

Improve Caregiver Well-being as reported on the Neuropsychological Inventory Questionnaire (NPI-Q) caregiver distress questions.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ADS PlusExperimental Treatment1 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 CareActive Control1 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.

0 / 2Eligibility criteria met