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ADS Plus Program for Caregiver Stress (ADS Plus Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 months
Awards & highlights
ADS Plus Trial 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.Check my eligibility
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.See study design
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.
ADS Plus Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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.
ADS Plus 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.
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Who is running the clinical trial?
University of MinnesotaOTHER
1,381 Previous Clinical Trials
1,550,784 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,267 Previous Clinical Trials
14,837,062 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,676 Previous Clinical Trials
28,020,999 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to use the device for at least 1 week over 6 months.Either I or my caregiver have been in the hospital more than 3 times last year.I plan to use the ADS device for at least 1 week over 6 months.I am 21 years old or older.I have given more than 8 hours of help to someone in the last week.My caregiver speaks English.I have a phone and agree to 4 interviews over a year.I or my caregiver is currently receiving treatment for a terminal illness or is in hospice care.I am a caregiver and I am 21 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: ADS Usual Care
- Group 2: ADS Plus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any active enrollments for this clinical trial currently?
"Affirmative. Clinicaltrials.gov has data indicating that this clinical trial, which was established on October 1st 2016, is currently recruiting participants. A total of 500 people need to be recruited from 2 distinct locations."
Answered by AI
What is the cap on participation for this investigation?
"Affirmative. The records on clinicaltrials.gov indicate that this scientific investigation, which was first posted in October of 2016, is currently recruiting patients for the trial. A total of 500 individuals must be enrolled from 2 different medical facilities."
Answered by AI
What objectives is this research endeavor attempting to fulfill?
"The purpose of this experiment, which will be supervised from the outset to 6 months post-intervention, is to assess Caregiver Wellbeing with a Perceived Change Scale. Cost Benefit of Intervention and Quality Adjusted Years of Life are also evaluated using the Resource Utilization in Dementia (RUD) scale and EuroQol-5 Dimension questionnaire respectively. Lastly, Long-term Care Placement risk reduction is tracked through caregiver reports at 6 and 12 month intervals."
Answered by AI
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