PPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA
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|ClinicalTrials.gov Identifier: NCT04412083|
Recruitment Status : Not yet recruiting
First Posted : June 2, 2020
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Primary Progressive Aphasia Caregiver Burnout||Behavioral: PPA Tele-Savvy Pilot Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Primary Progressive Aphasia (PPA) Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA|
|Estimated Study Start Date :||July 30, 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
PPA Tele-Savvy Pilot Intervention
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
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.
- 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.
- Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, 6-week follow-up ]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 [ Time Frame: Baseline, 6-week follow-up ]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 [ Time Frame: Baseline, 6-week follow-up ]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 [ Time Frame: Baseline, 6-week follow-up ]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 [ Time Frame: Baseline, 6-week follow-up ]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 [ Time Frame: Baseline, 6-week follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412083
|Contact: Darby Morhardt, PhDemail@example.com|
|Contact: Jordan Behnfirstname.lastname@example.org|
|United States, Illinois|
|Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Darby Morhardt, PhD||Northwestern University|
|Study Chair:||Darby Morhardt, PhD||Northwestern University|
|Study Director:||Darby Morhardt, PhD||Northwestern University|