Clinical trial NCT04412083: PPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA
Official title: Primary Progressive Aphasia (PPA) Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Caregiver Burnout
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2020-06-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score
timeFrame: Baseline, 6-week follow-up
Secondary outcomes:
measure: Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, 6-week follow-up
measure: Change in Caregiver Burden The Zarit Burden Interview score
timeFrame: Baseline, 6-week follow-up
measure: Change in Caregiver Stress Perceived Stress Survey score
timeFrame: Baseline, 6-week follow-up
measure: Change in Positive Aspects of Caregiving (PCOS) Scale score
timeFrame: Baseline, 6-week follow-up
measure: Change in Care recipient quality of life DEMQOL: Dementia Quality of Life Measure (Carer v4) score
timeFrame: Baseline, 6-week follow-up
measure: Change in Behavioral and Psychological Symptoms of Dementia Revised Memory and Behavior Problem Checklist (RMBPC) score
timeFrame: Baseline, 6-week follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Darby Morhardt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Darby Morhardt, PhD
role: STUDY_CHAIR
affiliation: Northwestern University
name: Darby Morhardt, PhD
role: STUDY_DIRECTOR
References: