Producing a Fully Asynchronous Online Savvy Program

Study Overview
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Brief Summary
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This is a pilot/feasibility study to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD).

Detailed Description
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This study seeks to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD). As the number of PLWD rises in the United States from the perhaps 7 million today to possibly 15 million in 2050, the healthcare system will rely on those caregivers even more. It is well established that family caregiving is taxing and stressful and that managing the day-to-day life of PLWD and handling the behavioral and psychological symptoms in dementia (BPSD) that they may exhibit are the main sources of stress. Group-based psychoeducational programs such as the Savvy Caregiver program (SCP) have demonstrated that the acquisition of skills, knowledge, and caregiving mastery can ameliorate caregiving stress - and enhance PLWD quality of life. Many factors, however, preclude caregivers' attendance in group-based programs and limit programs' scalability. To address the issue of access, the researchers have developed the Tele-Savvy program, an online version of SCP that brings groups of caregivers together in facilitator-led synchronous groups and provides substantive educational augmentation through asynchronous e-mail-delivered video lessons. The first aim of this study is to develop a fully asynchronous online Savvy program that incorporates learning activities that promote both knowledge and skill acquisition and develop and enhance caregivers' felt-sense of caregiving mastery. Developing this education program will utilize input from clinicians, educators, Tele-Savvy facilitators, and caregiver advisors. The second study aim is to determine the feasibility, acceptability and preliminary efficacy of the created online program. This study will recruit 60 family caregivers to take part in a no-control trial of the program. Data will be gathered at baseline, immediately upon course completion and at 3 months post-baseline to assess caregiver distress measures (depression, strain, burden, anxiety), caregiver competence/ mastery, and care recipient quality of life.

Official Title
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Producing a Fully Asynchronous Online Savvy Program

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Fully Asynchronous Online Savvy Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary unpaid caregiver for a community-dwelling PLWD provide at least 10 hours of direct care per week able to read and understand English be able to access the course online naïve to Savvy or Tele-Savvy Exclusion Criteria: cannot provide consent prisoners cognitively impaired adult not able to clearly understand English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fully Asynchronous Online Savvy Program<br>Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. | Behavioral: Fully Asynchronous Online Savvy Program<br>* The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants will be asked to engage with a fully online version of Tele-Savvy for 42 days. Participants will receive a series of daily video lessons related to caregiving. These lessons are generally 8-15 minutes in length and are emailed to participants. Participants can watch the lessons whenever and as often as they wish over the course of the study. There will also be self-guided learning strategies and exercises to accomplish skill and mastery related to the caregiving role. The lessons cover a variety of topics including: Facts about dementing Illnesses Caregiving Strategies - guiding the person through days that are as safe, calm, and pleasant as possible Self-Care for the Caregiver<br>* Other names: Tele-Savvy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Center for Epidemiologic Studies - Depression (CES-D) Score | The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 1 to 4 where 1 = rarely and 4 = most of the time. Total scores range from 20 to 80 and higher scores indicate greater symptoms of depression. | Baseline, Month 2, Month 3 | 
| Change in Zarit Burden Interview Score | The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care. | Baseline, Month 2, Month 3 | 
| Change in State-Trait Anxiety Inventory (STAI) Score | The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety. | Baseline, Month 2, Month 3 | 
| Change in Caregiver Mastery Scale Score | The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The 14 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 14 to 56 where higher scores indicate greater feelings of mastery of caregiving. | Baseline, Month 2, Month 3 | 
| Change in Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD. | Baseline, Month 2, Month 3 | 
| Change in Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD. | Baseline, Month 2, Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia caregiver