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

NCT02927821 | Completed DMC

• 2 other identifiers: IRB001125461R01AG049692-01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stress

Keywords

Adult Day Care Centers; Caregivers

Outcome Measures

Primary Outcomes (4)

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

  Caregiver Well-being will be measured using Perceived Change Scale. This is a 13-item scaled scored on a 5-point Likert scale with 1 = gotten much worse to 5 = improved a lot with higher scores indicating better well-being.

  from baseline to 6 months

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

  Caregiver Well-being will be measured using Perceived Change Scale. This is a 13-item scaled scored on a 5-point Likert scale with 1 = gotten much worse to 5 = improved a lot with higher scores indicating better well-being.

  from baseline to 12 months

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

  Caregiver depressive symptoms will be measured using the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20 item scale, scored 0 to 3 for each item. Zero means rarely or none of the time and 3 means most or all of the time. Lower scores indicate less depressive symptoms.

  from baseline to 6 months

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

  Caregiver depressive symptoms will be measured using the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20 item scale, scored 0 to 3 for each item. Zero means rarely or none of the time and 3 means most or all of the time. Lower scores indicate less depressive symptoms.

  from baseline to 12 months

Secondary Outcomes (4)

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

  baseline to 6 months

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

  Baseline to 6 months

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

  from baseline to 6 months

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

  from baseline to 12 months

Study Arms (2)

ADS Plus

EXPERIMENTAL

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.

Behavioral: ADS Plus

ADS Usual Care

NO 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.

Interventions

ADS Plus BEHAVIORAL

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

Also known as: Adult Day Services Plus, ADS+

ADS Plus

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers are eligible to participate at time of intake at an Adult Day Service (ADS) if they:
• are initially enrolling their relative in one of the 30 participating ADS sites
• expect to use ADS for a minimum of 1 week for 6 months
• have primary responsibility for care of the ADS client
• speak English
• provided \> 8 hours of assistance to client in past week
• have a telephone and are willing to participate in 4 telephone interviews (baseline, 3 month check-in; 6 and 12 month follow-ups)
• are 21 years of age or older (male or female).

You may not qualify if:

• caregivers and older adult clients are not eligible if:
• they plan to move from the area within 6 months
• either caregiver or client has been hospitalized \>3 times in past year
• either caregiver or client is in active treatment for a terminal illness or are in hospice
• caregiver is involved in other caregiver support services/trials.

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Minnesota: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (6)

• Gitlin LN, Reever K, Dennis MP, Mathieu E, Hauck WW. Enhancing quality of life of families who use adult day services: Short- and long-term effects of the adult day services plus program. Gerontologist. 2006 Oct;46(5):630-9. doi: 10.1093/geront/46.5.630.

  PMID: 17050754 RESULT

• Gitlin LN, Marx KB, Roth DL, Anderson K, Dabelko-Schoeny H, Scerpella D, Parker LJ, Koeuth S, Gaugler JE. Fidelity matters: implementing ADS Plus, an evidence-based program, in multiple adult day service sites. Innov Aging. 2025 Jul 1;9(8):igaf074. doi: 10.1093/geroni/igaf074. eCollection 2025 Aug.

  PMID: 40979469 DERIVED

• Cotton QD, Bailey D, Albers E, Ingvalson S, Bloomquist E, Marx K, Anderson K, Dabelko-Schoeny H, Parker L, Gitlin LN, Gaugler JE. Understanding the implementation process of the Adult Day Services Plus program. BMC Geriatr. 2025 Feb 13;25(1):95. doi: 10.1186/s12877-025-05757-4.

  PMID: 39948465 DERIVED

• Gitlin LN, Roth DL, Marx K, Parker LJ, Koeuth S, Dabelko-Schoeny H, Anderson K, Gaugler JE. Embedding Caregiver Support Within Adult Day Services: Outcomes of a Multisite Trial. Gerontologist. 2024 Apr 1;64(4):gnad107. doi: 10.1093/geront/gnad107.

  PMID: 37549428 DERIVED

• Parker LJ, Marx KA, Nkimbeng M, Johnson E, Koeuth S, Gaugler JE, Gitlin LN. It's More Than Language: Cultural Adaptation of a Proven Dementia Care Intervention for Hispanic/Latino Caregivers. Gerontologist. 2023 Mar 21;63(3):558-567. doi: 10.1093/geront/gnac120.

  PMID: 35951488 DERIVED

• Gitlin LN, Marx K, Scerpella D, Dabelko-Schoeny H, Anderson KA, Huang J, Pizzi L, Jutkowitz E, Roth DL, Gaugler JE. Embedding caregiver support in community-based services for older adults: A multi-site randomized trial to test the Adult Day Service Plus Program (ADS Plus). Contemp Clin Trials. 2019 Aug;83:97-108. doi: 10.1016/j.cct.2019.06.010. Epub 2019 Jun 22.

  PMID: 31238172 DERIVED

Study Officials

• Laura Gitlin, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Joseph Gaugler, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: October 7, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)