Caregivers of Alzheimer's Disease or Memory Problem Patients Clinical Trial
Official title:
A Tailored Technology Intervention for Diverse Caregivers of AD Patients
| Verified date | June 2019 |
| Source | University of Miami |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with Alzheimer's Disease. The overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.
| Status | Completed |
| Enrollment | 244 |
| Est. completion date | April 20, 2018 |
| Est. primary completion date | April 20, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Speak and understand English or Spanish 2. Provide care to a loved one with memory decline 3. Not having terminal illness/condition 4. 18+ yrs old Exclusion Criteria: 1. Not providing care to a loved one with Alzheimer disease or dementia 2. Not speak English or Spanish 3. Have cognitive deficit 4. Have terminal illness 5. Plan to place their loved one in a facility 6. Plan to move away in the next 12 months |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Miami Miller School of Medicine | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Miami | National Institute of Nursing Research (NINR) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms. | Baseline, 6-mth follow-up and 12-mth follow-up | |
| Primary | Caregiving Burden as Measured by Burden Inventory | Higher score means greater level of caregiver burden. Range (0-44) | Baseline, 6-mth follow-up and 12-mth follow-up | |
| Primary | Caregiver's Self Report of Self-care | A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself. | Baseline, 6-mth follow-up and 12-mth follow-up | |
| Primary | Caregiver's Self-report of Physical Health | SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health. | Baseline, 6-mth follow-up and 12-mth follow-up | |
| Primary | Caregiver's Self-efficacy | A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy. | Baseline, 6-mth follow-up and 12-mth follow-up | |
| Primary | Positive Aspects of Caregiving | An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving. | Baseline, 6-mth follow-up and 12-mth follow-up |