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Clinical Trials/NCT04412083
NCT04412083
Completed
Not Applicable

Primary Progressive Aphasia (PPA) Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA

Northwestern University1 site in 1 country29 target enrollmentJuly 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Progressive Aphasia
Sponsor
Northwestern University
Enrollment
29
Locations
1
Primary Endpoint
Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score
Status
Completed
Last Updated
last year

Overview

Brief Summary

The primary goal of this pilot project is to adapt an evidence-informed on-line psychoeducation program (Tele-Savvy) to address the unique challenges facing informal caregivers of those living with PPA and geared toward achieving caregiver mastery in this population.

Detailed Description

The primary goal of this pilot project is to develop an evidence-informed on-line psychoeducation program (Tele-Savvy) based on the well-established Savvy Caregiver program to address the unique challenges facing informal caregivers of those living with Primary Progressive Aphasia (PPA) and to help these caregivers achieve mastery. Key elements of the adaptation process are to identify and adapt mechanistic elements of the Tele-Savvy intervention (increasing self-efficacy, mastery of new skills, increased knowledge of disease-specific symptoms and trajectories, problem-solving skills). We will engage PPA caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and then pilot test the adapted PPA Tele-Savvy program.

Registry
clinicaltrials.gov
Start Date
July 30, 2020
End Date
September 19, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Informal (family or friends) caregivers of persons living with or deceased from PPA.
  • Age 18 or over Providing or have provided at least 2 hours per day of unpaid assistance, on average, for a person in the early-middle stage of PPA.
  • Must have access to a computer with adequate internet connection. Able to use a videoconferencing platform and receive email. Participants must be able to read, speak and understand English and have no uncorrectable vision or hearing deficits that might impede participation.
  • Informal (family or friends) caregivers of persons living with PPA. Age 18 or over Providing at least 2 hours per day of unpaid assistance, on average, for a person in the early-middle stage of PPA.
  • Must have access to a computer with adequate internet connection. Able to use a videoconferencing platform and receive email. Must be able to read, speak and understand English and have no uncorrectable vision or hearing deficits that might impede participation.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score

Time Frame: Baseline, 6-week follow-up

Comprised of 6 domains from the full Pearlin Stress Scale. 1. Relational Deprivation: 6-24, higher scores indicate increased relational deprivation. 2. Role Captivity: 3 - 12, higher scores indicate an increased feeling of being trapped in the caregiver role. 3. Loss of Self: 2 - 8, higher scores indicate a greater loss of self. 4. Caregiving competence: 4 - 16, higher scores indicate greater caregiving competence. 5. Management of Situation: 4 - 16, higher scores indicate better management of the caregiving situation. 6. Management of Meaning: 9 - 36, higher scores indicate a better management of the meaning of the caregiving role.

Secondary Outcomes

  • Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, 6-week follow-up)
  • Change in Positive Aspects of Caregiving (PCOS) Scale score(Baseline, 6-week follow-up)
  • Change in Caregiver Burden The Zarit Burden Interview score(Baseline, 6-week follow-up)
  • Change in Care recipient quality of life DEMQOL: Dementia Quality of Life Measure (Carer v4) score(Baseline, 6-week follow-up)
  • Change in Behavioral and Psychological Symptoms of Dementia Revised Memory and Behavior Problem Checklist (RMBPC) score(Baseline, 6-week follow-up)
  • Change in Caregiver Stress Perceived Stress Survey score(Baseline, 6-week follow-up)

Study Sites (1)

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