Producing a Fully Asynchronous Online Savvy Program

Browse trials for

• Dementia 2,231

Keywords

• Dementia caregiver

Dementia

2,231 studies on the registry are indexed under Dementia; 549 are open to participants now.

This study's enrollment of 60 is below the median of 83 across 1,669 interventional studies indexed under Dementia.

Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.

Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.

Study arms

• Experimental
  Fully Asynchronous Online Savvy Program

  Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program.

  Behavioral: Fully Asynchronous Online Savvy Program

Interventions

• BehavioralFully Asynchronous Online Savvy Program

  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

  Also known as: Tele-Savvy

Primary outcomes

1. 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 0 to 3 where "rarely" = 0 and "most of the time" = 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.

   Time frame: Baseline, Month 2, Month 3

2. 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.

   Time frame: Baseline, Month 2, Month 3

3. 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.

   Time frame: Baseline, Month 2, Month 3

4. Caregiver Mastery Scale - Caregiving Competence Score

   The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence subscale asks caregivers about their thoughts about the caregiving they provide with 4 items where responses are given on a 4-point scale where "not at all" = 1 and "completely" or "very" = 4. Total scores range from 4 to 16 where higher scores indicate greater feelings of competence with caregiving.

   Time frame: Baseline, Month 2, Month 3

5. 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.

   Time frame: Baseline, Month 2, Month 3

6. 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.

   Time frame: Baseline, Month 2, Month 3

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · May 14, 2020
• Informed consent form · Aug 19, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All of the individual participant data collected during the trial will be made available for sharing with other researchers, after deidentification.

Supporting information: Study protocol

Time frame: Sharing will begin 3 months and end 5 years following article publication.

Access criteria: Individual participant data will be made available to researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal. Proposals should be directed to Dr. Epps at fepps@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.