Dementia Caregiving Clinical Trial
Official title:
A Daily Self-Regulation Intervention for Persons With Early Stage Alzheimer's Disease and Related Dementias and Their Spouses
| Verified date | February 2024 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a study designed to pilot a WOOP (Wish Outcome Obstacle Plan) intervention for spouses of persons with early stage dementia for the purposes of future research. The investigators will be using two cohorts. One who will get the intervention and the other who will be wait listed and receive the intervention at a later date. Spouses of persons with dementia will use WOOP, a brief goal attainment sequence, every day for 16 days. Participants will complete surveys before the intervention, at Day 16, and at a 3-month follow-up. The outcome measures are goal attainment, emotion regulation skills, psychological health, and support quality. As of 9/2020 this entire study is being conducted remotely.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | June 30, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | Inclusion/Exclusion Criteria: - The couple is married or in a cohabiting, committed relationship. - One partner has early Adult Dementia (AD) or a related dementia using criteria: symptoms consistent with early-stage dementia or memory impairment (e.g., AD, vascular dementia) and scores on the Neuropsychiatric Inventory (NPI) =3; Mini-Mental State Examination (MMSE) =18 and =27; and Barthel Index (BI) =5 and =1923. Or>20 on Telephone Interview for Cognitive Status. (TICS) - The spouse will have to score 27 or higher on the MMSE. Or>25 on TICS. - Both participants must agree to participate and complete baseline interviews. - Both partners are at least 60 years old. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Joan Monin | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University | National Institute on Aging (NIA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Perceived Stress | The Perceived Stress Scale (PSS-10) will be used to examine participants' stress over the past week. There are 10 items rated on a scale from 0 to 4. Greater scores indicate greater stress. Sum scores can range from 0 to 40 with 40 being the highest stress and 0 being the lowest. | baseline, 3 months | |
| Primary | Change in Positive Affect | Nine self-reported positive emotions (e.g., amusement, gratitude, hope) on a 1-5 scale over the past week using the Positive and Negative Affect Schedule (25 items). Higher scores indicate more positive emotions. Mean scores can range from 1 to 5 with 5 being the highest experience of positive emotions. | baseline, 3 months | |
| Primary | Change in Depressive Symptoms | 10-item Center for Epidemiologic Studies of Depression Scale (CESD). Participants rate on a scale from 0 to 3. Higher numbers indicate more depressive symptoms. Sum scores can range from 0 to 30 with higher sums cores meaning more depressive symptoms. | baseline, 3 months | |
| Primary | Change in Quality of Life | Quality of life was measured with the Quality of Life in Alzheimer's Disease (QOL-AD). The QOL-AD consists of 13 items that capture multiple aspects of a person's quality of life in the context of dementia. It can also be used to examine the quality of life of family members of persons with dementia. Participants rate on a 5-point scale from poor to excellent the degree to which they feel about different aspects of their life (e.g. physical health, energy, mood, memory, family). Sum scores can range from 13 to 65 with higher scores meaning higher quality of life. | baseline, 3 months | |
| Primary | Change in Negative Emotions | Ten negative (e.g., irritable, distressed) adjectives were measured with the Positive and Negative Affect Scale. Each item has a score of 1 (not at all) to 5 (extremely). The mean of the 10 items will be measured. Mean scores can range from 1 to 5 with 5 meaning the highest experience of negative emotions. | baseline, 3 months |