PPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA

NCT04412083 | Completed

• 1 other identifier: STU00210711
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Progressive Aphasia; Caregiver Burnout

Outcome Measures

Primary Outcomes (1)

• Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score

  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.

  Baseline, 6-week follow-up

Secondary Outcomes (6)

• Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D)

  Baseline, 6-week follow-up

• Change in Caregiver Burden The Zarit Burden Interview score

  Baseline, 6-week follow-up

• Change in Caregiver Stress Perceived Stress Survey score

  Baseline, 6-week follow-up

• Change in Positive Aspects of Caregiving (PCOS) Scale 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

Study Arms (1)

PPA Tele-Savvy Pilot Intervention

OTHER

The Tele-Savvy program is comprised of weekly, two-hour interactive classes, over seven consecutive weeks, the same duration as the proposed intervention. Tele-Savvy consists of educational instruction, video and in-class exercises that engage participants on a functional level. Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a person living with dementia (PLWD). Course learning objectives include: 1) introduction to dementing disorder; 2) caregiver self-care; 3) the anchors of contented involvement; 4) levels of thinking and performance; 5) strengthening the family as a resource for caregiving; and 6) review and integration of the previous sections.

Behavioral: PPA Tele-Savvy Pilot Intervention

Interventions

PPA Tele-Savvy Pilot Intervention BEHAVIORAL

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.

PPA Tele-Savvy Pilot Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1:
• 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.
• Aim 2:
• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Emory University: collaborator

Study Sites (1)

Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive; Caregiver Burden

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Darby Morhardt, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Darby Morhardt, PhD

  Northwestern University

  STUDY CHAIR

• Darby Morhardt, PhD

  Northwestern University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: July 30, 2020
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)