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
|Condition or disease||Intervention/treatment||Phase|
|Stress||Behavioral: ADS Plus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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|
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
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Katherine Marx, PhDemail@example.com|
|Contact: Daniel Scerpella, BAfirstname.lastname@example.org|
|United States, Maryland|
|Baltimore, Maryland, United States, 21205|
|Contact: Katherine Marx, PhD 443-287-8633 email@example.com|
|Contact: Kasey Burke 443-287-4595 firstname.lastname@example.org|
|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 email@example.com|
|Sub-Investigator: Carolyn Garcia Porta, PhD|
|Sub-Investigator: Cynthia Peden-McAlpine, PhD|
|Principal Investigator:||Laura Gitlin, PhD||Johns Hopkins University|
|Principal Investigator:||Joseph Gaugler, PhD||University of Minnesota|