Caregiving During Crisis

NCT04939714 | Completed Results

• 2 other identifiers: STUDY000014243P30AG064200-02S1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test a prototype pandemic caregiver training and education course designed for caregivers of persons living with dementia (PLWD). Participants will be randomized to take the course immediately or to take the course after completion of an 8-week waiting period.

Conditions

Caregiver Stress Syndrome

Keywords

Dementia family caregiver; Online education

Outcome Measures

Primary Outcomes (8)

• Center for Epidemiologic Studies - Depression (CES-D) Scale 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 is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.

  Baseline, Week 8

• 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, Week 8

• Perceived Stress Scale (PSS-14) Score

  The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress.

  Baseline, Week 8

• 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 person living with dementia (PLWD).

  Baseline, Week 8

• 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, Week 8

• 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, Week 8

• Caregiver Mastery Scales - Competency 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 section includes 4 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 4 to 16 where higher scores indicate greater feelings of mastery of caregiving.

  Baseline, Week 8

• Caregiver Assessment of Behavioral Skill - Self-report Score

  The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care.

  Baseline, Week 8

Study Arms (2)

Psychoeducational Intervention

EXPERIMENTAL

Caregivers receiving the psychoeducational intervention immediately.

Behavioral: Psychoeducational Intervention

Waitlist

NO INTERVENTION

Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.

Interventions

Psychoeducational Intervention BEHAVIORAL

The intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care).

Psychoeducational Intervention

Eligibility Criteria

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

You may qualify if:

• Providing care for a family member or friend with a confirmed diagnosis of dementia
• Lives in the community
• Co-resides with the PLWD
• Is the main caregiver for the PLWD
• Has access to a computer with internet service
• Can read and understand English

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Results Point of Contact

• Title: Carolyn Clevenger, DMP, APRN
• Organization: Emory University

carolyn.clevenger@emory.edu

404-712-2394

Study Officials

• Carolyn Clevenger, DNP, APRN

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: June 7, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data will be available for sharing beginning 3 months and ending 5 years following article publication.
• Access Criteria: Individual participant data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal. Proposals should be directed to carolyn.clevenger@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)