Alzheimer Disease Clinical Trial
— READyROfficial title:
READyR: A Remote Assessment and Dynamic Response Intervention to Support Couples in Planning for Changing Dementia Care Needs
Verified date | June 2022 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the READyR study (originally called SHARE-sense) is to redevelop and test an intervention program to remotely assess for changing dementia-related care needs.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 17, 2022 |
Est. primary completion date | June 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 62 Years and older |
Eligibility | Persons with Dementia Inclusion: 1. 62 years or older; 2. Able to identify a family care partner over age 20 who is living with you and will also consent to fully participate in the study; 3. Probable or confirmed diagnosis of mild cognitive impairment or early-stage dementia 4. Age and education adjusted MOCA score > 15 (at most recent measurement by parent study) corresponding to early to moderate stage dementia Exclusion: 1. Inability to speak English or read printed materials in English 2. Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials); 3. Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers. Family Care Partners Inclusion: 1. 21 years or older; 2. Self-identifying as a family member and care partner residing with the PwD participant; Exclusion: 1. Inability to speak English or read printed materials in English 2. Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials); 3. Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers. |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs | The Preparation for Future Care Needs Scale (Short Form) assesses the degree to which an individual has engaged in planning for future care needs in late life using 15 items and 5 subscales representing distinct planning processes (awareness, gathering information, decision making, concrete planning, avoidance). Items are scored on a 5 point Likert scale with higher scores indicating greater preparation for future care needs. Sorensen, S., Chapman, B. P., Duberstein, P. R., Pinquart, M., & Lyness, J. M. (2017). Assessing future care preparation in late life: Two short measures. Psychol Assess, 29(12), 1480-1495. | Baseline, 6 weeks, 12 weeks | |
Primary | Mean difference effect sizes for pre-post change in the care dyad's relationship quality | The Dyadic Relationship Scale assesses the positive dyadic interactions and negative dyadic strain experienced by caregivers (11 items) and care recipients (10 items). Items are averaged for a summary score that ranges from 0 to 3, with higher scores indicating more positive interactions in the relationship, or more relationship strain, respectively. Sebern, M.D. & Whitlatch, C.J. (2007). Dyadic Relationship Scale: A measure of the impact of the provision and receipt of family care. The Gerontologist, 47(6), 741-751. | Baseline, 6 weeks, 12 weeks | |
Secondary | Mean difference effect sizes for pre-post change in care-related strain | Subjective strain from caregiving will be assessed among family care partners at baseline and follow-up assessments using the Zarit Burden Interview (ZBI), short-form (12 items). Scores range from 0-48 with higher scores indicating a greater degree of strain from providing care. | Baseline and weekly for 12 weeks | |
Secondary | Mean difference effect sizes for pre-post change in quality of life | The Quality of Life: Alzheimer's Disease Scale assesses individual perceptions of quality of life (from poor to excellent) across 13 items. Items are averaged for a summary score of 1 to 4, higher scores indicating greater degree of quality of life. Logsdon, R. G., Gibbons, L. E., McCurry, S. M., & Teri, L. (1999). Quality of Life in Alzheimer's Disease: Patient and Caregiver Reports. Journal of Mental Health and Aging, 5(1), 21-32. | Baseline, 6 weeks, and 12 weeks | |
Secondary | Mean difference effect sizes for pre-post change in concealment of emotions. | The Emotional Intimacy Disruptive Behavior Scale (8 items) assesses the frequency of engagement in behaviors to conceal emotions about an illness from one's partner. Druley, J. A., Stephens, M. A. P., & Coyne, J. C. (1997). Emotional and physical intimacy in coping with Lupus: Women's dilemmas of disclosure and approach. . Health Psychology, 16, 506-514. | Baseline, 6 weeks, and 12 weeks |
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