Stress Clinical Trial
— ADS PlusOfficial title:
Improving Outcome for Family Caregivers of Older Adults With Complex Conditions: The Adult Day Plus (ADS Plus) Program
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Aging (NIA), University of Minnesota |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Cost Analysis of Intervention as assessed by the Resource Utilization in Dementia (RUD) | 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. | baseline to 6 months | |
Secondary | Cost Analysis of Intervention as assessed by the Service Utilization and Resources Survey (SURF) | Cost will be computed using the Service Utilization and Resources Survey (SURF). This survey asks about healthcare service use and time spent with care. | Baseline to 6 months | |
Secondary | Improve Caregiver Well-being as reported on the Neuropsychological Inventory Questionnaire (NPI-Q) caregiver distress questions. | 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. | from baseline to 6 months | |
Secondary | Improve Caregiver Well-being as reported on the Neuropsychological Inventory Questionnaire (NPI-Q) caregiver distress questions. | 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. | from baseline to 12 months |
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