Producing a Fully Asynchronous Online Savvy Program

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).

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Fully Asynchronous Online Savvy Program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fully Asynchronous Online Savvy Program; Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program.

Behavioral: Fully Asynchronous Online Savvy Program; The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants will be asked to engage with a fully online version of Tele-Savvy for 42 days. Participants will receive a series of daily video lessons related to caregiving. These lessons are generally 8-15 minutes in length and are emailed to participants. Participants can watch the lessons whenever and as often as they wish over the course of the study. There will also be self-guided learning strategies and exercises to accomplish skill and mastery related to the caregiving role. The lessons cover a variety of topics including: Facts about dementing Illnesses; Caregiving Strategies - guiding the person through days that are as safe, calm, and pleasant as possible; Self-Care for the Caregiver; Other Names: Tele-Savvy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center for Epidemiologic Studies - Depression (CES-D) Score	The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where "rarely" = 0 and "most of the time" = 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.	Baseline, Month 2, Month 3
Zarit Burden Interview Score	The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.	Baseline, Month 2, Month 3
State-Trait Anxiety Inventory (STAI) Score	The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.	Baseline, Month 2, Month 3
Caregiver Mastery Scale - Caregiving Competence Score	The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence subscale asks caregivers about their thoughts about the caregiving they provide with 4 items where responses are given on a 4-point scale where "not at all" = 1 and "completely" or "very" = 4. Total scores range from 4 to 16 where higher scores indicate greater feelings of competence with caregiving.	Baseline, Month 2, Month 3
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score	The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD.	Baseline, Month 2, Month 3
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score	The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.	Baseline, Month 2, Month 3

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Carolyn Clevenger, DNP, RN, Emory University; Principal Investigator: Fayron Epps, PhD, RN, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dementia caregiver
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: STUDY00000749; 3P30AG064200-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial will be made available for sharing with other researchers, after deidentification.
• IPD Sharing Time Frame: Sharing will begin 3 months and end 5 years following article publication.
• IPD Sharing Access Criteria: Individual participant data will be made available to researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal. Proposals should be directed to Dr. Epps at fepps@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No