Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02927821
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02927821
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : June 18, 2020
Sponsor:
Collaborators:
University of Minnesota
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Stress Behavioral: ADS Plus Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Outcome for Family Caregivers of Older Adults With Complex Conditions: The Adult Day Plus (ADS Plus) Program
Study Start Date : October 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: ADS Plus
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
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
Other Names:
  • Adult Day Services Plus
  • ADS+

No Intervention: ADS Usual Care
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.



Primary Outcome Measures :
  1. Improve Caregiver Well-being as assessed by the Perceived Change Scale [ Time Frame: from baseline to 6 months after intervention ]
    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.

  2. Decrease Depressive Symptoms in Caregivers as assessed by Center for Epidemiological Studies Depression Scale (CES-D). [ Time Frame: from baseline to 6 months after intervention ]
    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.

  3. Improve Caregiver Well-being as assessed by the Zarit Burden Interview [ Time Frame: from baseline to 6 months after intervention ]
    Caregiver well-being will be measured using the Zarit Burden Interview. There are 22 items, scored on a 5-point Likert Scale 0 = Never to 4 = nearly always with lower scores indicating less burden.

  4. Improve Caregiver Well-being as reported on the Neuropsychological Inventory Questionnaire (NPI-Q) caregiver distress questions. [ Time Frame: from baseline to 6 months after intervention ]
    Caregiver well-being will be measured using Caregiver stress as reported on the Neuropsychological Inventory Questionnaire (NPI-Q). The NPI-Q is a 12 item scale where caregiver distress is scored on a 6 point Likert Scale with zero equal to not at all distressing to 5 meaning extreme or very severe distress. Higher Scores indicate more distress.


Secondary Outcome Measures :
  1. Decrease risk of Long-term Care Placement [ Time Frame: baseline to 12 months after intervention ]
    The caregiver will be asked at 6 months and 12 months to report if the person they care for is still living with them or has been placed in long-term care.

  2. Cost Benefit of Intervention as assessed by the Resource Utilization in Dementia (RUD) [ Time Frame: baseline to 6 months ]
    Cost will be computed using the Resource Utilization in Dementia (RUD). The RUD scale assess use of social services, frequency and duration of hospitalizations, contact with health care professionals, time spent caring for the person with dementia, missed word and medication use.

  3. Cost Benefit of Intervention as assessed by the Service Utilization and Resources Survey (SURF) [ Time Frame: Baseline to 6 months ]
    Cost will be computed using the Service Utilization and Resources Survey (SURF). This survey asks about healthcare service use and time spent with care.

  4. Quality Adjusted Years of Life as assessed by he EuroQol-5 dimension questionnaire [ Time Frame: Baseline to 6 months ]
    Quality Adjusted years of life will be computed using the EuroQol-5 dimension questionnaire. The EuroQol-5 Dimension is a 5 item scale measuring disability in 5 domains (mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each domain is scored on a 3 point scale from none to extreme.

  5. Quality Adjusted Years of Life as assessed by the Health Utilities Index proxy version (HUI) [ Time Frame: Baseline to 6 months ]
    Quality Adjusted years of life will be computed using the Health Utilities Index proxy version (HUI). The HUI is a 15-item questionnaire that assesses ability/disability in 15 domains of health. They are scored on separate scales but in all lower scores indicate less disability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927821


Contacts
Layout table for location contacts
Contact: Katherine Marx, PhD 443-287-8633 kmarx1@jhu.edu
Contact: Daniel Scerpella, BA 410-502-2604 dscerpe1@jhu.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Katherine Marx, PhD    443-287-8633    kmarx1@jhu.edu   
Contact: Kasey Burke    443-287-4595    kburke32@jhu.edu   
Sub-Investigator: Quincy Samus, PhD         
Sub-Investigator: David Roth, PhD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Joseph Gaugler, PhD    612-626-2485    gaug0015@umn.edu   
Sub-Investigator: Carolyn Garcia Porta, PhD         
Sub-Investigator: Cynthia Peden-McAlpine, PhD         
Sponsors and Collaborators
Johns Hopkins University
University of Minnesota
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Laura Gitlin, PhD Johns Hopkins University
Principal Investigator: Joseph Gaugler, PhD University of Minnesota
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02927821    
Other Study ID Numbers: IRB00112546
1R01AG049692-01 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johns Hopkins University:
Adult Day Care Centers
Caregivers