Producing a Fully Asynchronous Online Savvy Program

NCT04951037 | Completed Results

• 2 other identifiers: STUDY000007493P30AG064200-02S1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia

Keywords

Dementia caregiver

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Fully Asynchronous Online Savvy Program

EXPERIMENTAL

Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program.

Behavioral: Fully Asynchronous Online Savvy Program

Interventions

Fully Asynchronous Online Savvy Program BEHAVIORAL

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

Also known as: Tele-Savvy

Fully Asynchronous Online Savvy Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Fayron Epps, PhD, RN
• Organization: Emory University

fepps@emory.edu

404-727-6936

Study Officials

• Fayron Epps, PhD, RN

  Emory University

  PRINCIPAL INVESTIGATOR

• Carolyn Clevenger, DNP, RN

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 6, 2021
• Study Start: September 15, 2021
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Sharing will begin 3 months and end 5 years following article publication.
• 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.

Locations

US (1)