Alzheimer's Disease and Related Dementias
Conditions
Brief summary
The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).
Detailed description
Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.
Interventions
BEHAVIORALResilient Together for Dementia
A novel live video dyadic resiliency intervention
Sponsors
National Institute on Aging (NIA)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PWD inclusion criteria are: * Recent (\ 1 month) chart documented ADRD diagnosis, * ADRD symptom onset after age 65 , * cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0 * cognitive awareness of his/her problems (as determined by the treating neurologist), and * ability to understand study and research protocol, as determined by a standardized teach-back method assessment84. Additional inclusion criteria for dyads are: * English speaking adults (18 years or older), * dyad lives together, * at least one partner endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression scale subscales)
Exclusion criteria
* patient is deemed inappropriate by the neurology team, * either partner has a co-occurring terminal illness, * patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of potential eligible participants | After each dyad completion, throughout study of 1.5-2 months | Feasibility of recruitment - Recruitment will be monitored by screening clinic visits for potentially eligible individuals and review recruitment progress in weekly meetings to promote completion within the study time frame. Recruitment will be monitored but will not set official benchmarks and modify procedures after each dyad. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants screened | After each dyad completion, throughout study of 1.5-2 months | Feasibility of screening - the portion of individuals who undergo screening that screen eligible and ineligible, and the reasons for ineligibility with detailed descriptions will be monitored and will review progress in weekly team meetings. Screening will be monitored but will not set official benchmarks and modify procedures after each dyad. |
| Proportion of participants who consent or not consent to participate | After each dyad completion, throughout study of 1.5-2 months | Feasibility of consent by keeping a record of all individuals who complete screening that consent, refuse to consent, and the reasons for refusal will be monitored and will review progress in weekly team meetings. Feasibility of consent will be monitored but will not set official benchmarks and modify procedures after each dyad. |
| Proportion of sessions participants attend | After each dyad completion, throughout study of 1.5-2 months | Feasibility of treatment -The number of sessions that enrolled dyads attend as well as missed sessions, treatment dropouts, and reasons for non attendance will be monitored and will review progress in weekly meetings. Feasibility of treatment will be monitored but will not set official benchmarks and modify procedures after each dyad. |
| Change in Hospital Anxiety and Depression Scale (HADS) | Baseline and 6 weeks (post-intervention) | Change in emotional distress assessed with the Hospital Anxiety and Depression Anxiety Scale which is a 14-items scale with responses scored from 0-3, scores for each subscale (anxiety and depression) from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress. |
Countries
United States
Outcome results
None listed