Clinical trial NCT04951037: Producing a Fully Asynchronous Online Savvy Program
Official title: Producing a Fully Asynchronous Online Savvy Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia caregiver
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot/feasibility study to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD).

Detailed description: This study seeks to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD). As the number of PLWD rises in the United States from the perhaps 7 million today to possibly 15 million in 2050, the healthcare system will rely on those caregivers even more. It is well established that family caregiving is taxing and stressful and that managing the day-to-day life of PLWD and handling the behavioral and psychological symptoms in dementia (BPSD) that they may exhibit are the main sources of stress. Group-based psychoeducational programs such as the Savvy Caregiver program (SCP) have demonstrated that the acquisition of skills, knowledge, and caregiving mastery can ameliorate caregiving stress - and enhance PLWD quality of life. Many factors, however, preclude caregivers' attendance in group-based programs and limit programs' scalability. To address the issue of access, the researchers have developed the Tele-Savvy program, an online version of SCP that brings groups of caregivers together in facilitator-led synchronous groups and provides substantive educational augmentation through asynchronous e-mail-delivered video lessons.

The first aim of this study is to develop a fully asynchronous online Savvy program that incorporates learning activities that promote both knowledge and skill acquisition and develop and enhance caregivers' felt-sense of caregiving mastery. Developing this education program will utilize input from clinicians, educators, Tele-Savvy facilitators, and caregiver advisors. The second study aim is to determine the feasibility, acceptability and preliminary efficacy of the created online program. This study will recruit 60 family caregivers to take part in a no-control trial of the program. Data will be gathered at baseline, immediately upon course completion and at 3 months post-baseline to assess caregiver distress measures (depression, strain, burden, anxiety), caregiver competence/ mastery, and care recipient quality of life.

Eligibility criteria: Inclusion Criteria:

* primary unpaid caregiver for a community-dwelling PLWD
* provide at least 10 hours of direct care per week
* able to read and understand English
* be able to access the course online
* naïve to Savvy or Tele-Savvy

Exclusion Criteria:

* cannot provide consent
* prisoners
* cognitively impaired adult
* not able to clearly understand English

Primary outcomes:
measure: Center for Epidemiologic Studies - Depression (CES-D) Score
timeFrame: Baseline, Month 2, Month 3
measure: Zarit Burden Interview Score
timeFrame: Baseline, Month 2, Month 3
measure: State-Trait Anxiety Inventory (STAI) Score
timeFrame: Baseline, Month 2, Month 3
measure: Caregiver Mastery Scale - Caregiving Competence Score
timeFrame: Baseline, Month 2, Month 3
measure: Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
timeFrame: Baseline, Month 2, Month 3
measure: Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
timeFrame: Baseline, Month 2, Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Fayron Epps, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Carolyn Clevenger, DNP, RN
role: PRINCIPAL_INVESTIGATOR
References: