Resilient Together for Dementia (RT-D)

Официальное название

Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis

Обзор

This study will evaluate the feasibility and preliminary efficacy of the novel Resilient Together for Dementia (RT-D) intervention for couples following dementia diagnoses. The primary target is emotional distress, and the program aims to prevent chronic distress in at-risk couples.

Подробное описание

Both persons living with dementia 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 has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.

A pilot feasibility randomized control trial (RCT; Aim 3; NIA Stage 1B; N=50 dyads) will be conducted of the refined RT-D versus a minimally enhanced educational control (MEUC, educational pamphlet). Primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness R01 (year 4) of RT-D vs. MEUC (NIA Stage II). In this subsequent R01, the researcher will examine RT-D's impact on emotional distress and quality of life outcomes and test mechanisms of change (individual and interpersonal resiliency skills) through mediation and moderation. The researcher will revise the approach if feasibility benchmarks are not met.

Вмешательства

• Поведенческое Resilient Together for Dementia
  RT-D has been developed based on feedback from couples and dementia clinicians as well as prior successful dyadic interventions. RT-D was developed based on the Recovering Together (RT) dyadic intervention for acute neurological illnesses and is being adapted to address the needs of couples navigating new dementia diagnoses.
• Поведенческое MEUC
  The MEUC condition was also developed based on the comparison trial in the Recovering Together dyadic intervention, and was adapted based on feedback from prior studies. The program is self-guided and provides educational information similar to the RT-D condition, but with no skills practice or weekly sessions with a therapist.

Первичные конечные точки

• Proportion of participants screened [Срок оценки: After each dyad completion, throughout study of 6-8 weeks]
• Proportion of participants who consent or not consent to participate [Срок оценки: After each dyad completion, throughout study of 6-8 weeks]
• Proportion of sessions participants attend [Срок оценки: After each dyad completion, throughout study of 6-8 weeks]
• Credibility and Expectancy Questionnaire (CEQ) [Срок оценки: After each dyad completion, throughout study of 6-8 weeks]
• Client Satisfaction Questionnaire [Срок оценки: After each dyad completion, throughout study of 6-8 weeks]

Вторичные конечные точки (3)

• Hospital Anxiety and Depression Scale [Срок оценки: Baseline to posttest (6-8 weeks)]
• Geriatric Depression Scale [Срок оценки: Baseline to posttest (6-8 weeks)]
• Perceived Stress Scale [Срок оценки: Baseline to posttest (6-8 weeks)]

Критерии участия

Критерии включения

• Recent (\~3 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 their problems (as determined by the treating neurologist), and ability to understand study and research protocol, as determined by a standardized teach-back method assessment

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 or <5 on the Geriatric Depression Scale)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brain Injury Research Center at Mount Sinai — New York

Идентификаторы

NCT: NCT06619327 · GCO 23-0519-0001 · 1K23AG075188

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗