Back to resultsPPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA
Primary Purpose
Primary Progressive Aphasia, Caregiver Burnout
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PPA Tele-Savvy Pilot Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Progressive Aphasia
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:
-
Sites / Locations
- Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PPA Tele-Savvy Pilot Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D)
A 20-item scale that represents a symptom cluster consisting of negative affect, positive affect, interpersonal problems, and somatic activity based on feelings over the past week.Scores range 0 - 60. A score of 0-16 indicates little to no symptomatology, a score of 16 or more indicates depression with higher scores indicating increased severity.
Change in Caregiver Burden The Zarit Burden Interview score
The interview was developed to measure subjective burden among caregivers of adults with dementia. The 22-item self-report inventory examines burden associated with functional/behavioral impairments and the home care situation. The items are worded subjectively, focusing on the affective response of the caregiver. Scores range 0 - 88. Lower scores indicate little to no burden. Higher scores indicate greater burden. A score of 17 or more is considered high burden.
Change in Caregiver Stress Perceived Stress Survey score
This questionnaire is comprised of 10 items from the Perceived Stress Scale. Scores range 0 - 40. Higher scores indicating higher perceived stress. A score of 0-13 would be considered low stress. Scores from 14-26 would be considered moderate stress. Scores from 27-40 indicate high perceived stress.
Change in Positive Aspects of Caregiving (PCOS) Scale score
Caregivers will be instructed that "In spite of all the difficulties involved in giving care to a family member with memory or health problems, good things can come out of caregiving experiences." The scale has 11 items, and overall scores range 0 - 44. Higher scores indicate a more positive view of the caregiving role while lower scores indicate less positive views of the caregiver role.
Change in Care recipient quality of life DEMQOL: Dementia Quality of Life Measure (Carer v4) score
This 32 item questionnaire will be used to assess mood, cognitive status, and overall quality of life of the care recipient. Scores range 31 - 124. Lower scores indicate no subjective concerns about cognition or general health, while higher scores indicate a greater subjective concern about cognition and general health.
Change in Behavioral and Psychological Symptoms of Dementia Revised Memory and Behavior Problem Checklist (RMBPC) score
This 24 item instrument measures the frequency of the care recipient's problem behaviors in the following domains: disruptive behavior (wandering, aggression), memory-related behavior (repeating questions and stories), and depression. Scores range 0 - 96 for frequency. Lower scores indicate little to no behavioral problems while higher scores indicate greater behavioral issues. Scores range 0 - 96 for reaction. Lower scores indicate little concern regarding the behavior on the part of the caregiver while higher scores indicate greater concern.
Full Information
NCT ID
NCT04412083
First Posted
May 29, 2020
Last Updated
April 21, 2023
Sponsor
Northwestern University
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT04412083
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia, Caregiver Burnout
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PPA Tele-Savvy Pilot Intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PPA Tele-Savvy Pilot Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score
Description
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.
Time Frame
Baseline, 6-week follow-up
Secondary Outcome Measure Information:
Title
Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D)
Description
A 20-item scale that represents a symptom cluster consisting of negative affect, positive affect, interpersonal problems, and somatic activity based on feelings over the past week.Scores range 0 - 60. A score of 0-16 indicates little to no symptomatology, a score of 16 or more indicates depression with higher scores indicating increased severity.
Time Frame
Baseline, 6-week follow-up
Title
Change in Caregiver Burden The Zarit Burden Interview score
Description
The interview was developed to measure subjective burden among caregivers of adults with dementia. The 22-item self-report inventory examines burden associated with functional/behavioral impairments and the home care situation. The items are worded subjectively, focusing on the affective response of the caregiver. Scores range 0 - 88. Lower scores indicate little to no burden. Higher scores indicate greater burden. A score of 17 or more is considered high burden.
Time Frame
Baseline, 6-week follow-up
Title
Change in Caregiver Stress Perceived Stress Survey score
Description
This questionnaire is comprised of 10 items from the Perceived Stress Scale. Scores range 0 - 40. Higher scores indicating higher perceived stress. A score of 0-13 would be considered low stress. Scores from 14-26 would be considered moderate stress. Scores from 27-40 indicate high perceived stress.
Time Frame
Baseline, 6-week follow-up
Title
Change in Positive Aspects of Caregiving (PCOS) Scale score
Description
Caregivers will be instructed that "In spite of all the difficulties involved in giving care to a family member with memory or health problems, good things can come out of caregiving experiences." The scale has 11 items, and overall scores range 0 - 44. Higher scores indicate a more positive view of the caregiving role while lower scores indicate less positive views of the caregiver role.
Time Frame
Baseline, 6-week follow-up
Title
Change in Care recipient quality of life DEMQOL: Dementia Quality of Life Measure (Carer v4) score
Description
This 32 item questionnaire will be used to assess mood, cognitive status, and overall quality of life of the care recipient. Scores range 31 - 124. Lower scores indicate no subjective concerns about cognition or general health, while higher scores indicate a greater subjective concern about cognition and general health.
Time Frame
Baseline, 6-week follow-up
Title
Change in Behavioral and Psychological Symptoms of Dementia Revised Memory and Behavior Problem Checklist (RMBPC) score
Description
This 24 item instrument measures the frequency of the care recipient's problem behaviors in the following domains: disruptive behavior (wandering, aggression), memory-related behavior (repeating questions and stories), and depression. Scores range 0 - 96 for frequency. Lower scores indicate little to no behavioral problems while higher scores indicate greater behavioral issues. Scores range 0 - 96 for reaction. Lower scores indicate little concern regarding the behavior on the part of the caregiver while higher scores indicate greater concern.
Time Frame
Baseline, 6-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darby Morhardt, PhD
Phone
312-908-9432
Email
d-morhardt@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Dowden, MSW
Phone
312-503-5671
Email
lauren.dowden@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darby Morhardt, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darby Morhardt, PhD
Organizational Affiliation
Northwestern University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Darby Morhardt, PhD
Organizational Affiliation
Northwestern University
Official's Role
Study Director
Facility Information:
Facility Name
Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darby Morhardt, PhD
Phone
312-908-9432
Email
d-morhardt@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA
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