CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 208 enrolled
Drug / intervention
ADS Plusbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02927821
NCT02927821N/ACompleted

Improving Outcome for Family Caregivers of Older Adults With Complex Conditions: The Adult Day Plus (ADS Plus) Program

Johns Hopkins University·interventional·Posted Oct 7, 2016·Updated Jun 27, 2025

In Brief

A clinical study evaluating ADS Plus for Stress. Completed, enrolled 208 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 7, 2016
Enrollment StartOct 1, 2016
Primary CompletionJun 1, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 9.7 years ago

Interventions

ADS Plusbehavioral

Contact occurs at a minimum for about 1 hour per month over 12 months (face-to-face/ telephone). Targeted education materials concerning clients' conditions and related matters are shared via email or traditional mail. The goal of each contact is to provide ongoing emotional support, situational counseling, education about importance of taking care of self, referrals/linkages and skills (e.g., stress reduction, behavioral management, how to talk with doctors). The care planning process is collaborative and flexible, reflecting CG fluctuating needs