Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program

Depression Clinical Trial

Official title:

Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300584
• Other study ID #: IRB00074715
• Status: Completed
• Phase: N/A
• First received: November 21, 2014
• Last updated: September 7, 2016
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to refine and test the web-based delivery of a well-established in-person group program that provides information and education to informal caregivers (family and friends) of persons with Alzheimer's disease (or related illnesses).

Description:

The pilot project proposed will allow the investigators to use telehealth methods to deliver the Savvy Caregiver, an evidence-based dementia caregiver psychoeducation program, to family caregivers of community-dwelling persons with dementing illnesses (PWD) for whom attending in-person meetings poses difficulties. The program - named Tele-Savvy - uses iPad and PC technology and on-line conferencing capacity to deliver the program through daily asynchronous self-learning modules and weekly, hour-long synchronous group meetings with program facilitators. Tele-Savvy addresses all of the learning objectives of the current in-person Savvy program (Savvy entails in-person participation in six weekly two-hour group sessions).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• an informal caregiver for a person with a dementing disorder, such as Alzheimer's disease

• able to speak, read, and understand English

• has access to a computer with internet connection

• lives in the US

Exclusion Criteria:

• unwilling to participate in data gathering

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Depression

Intervention

Behavioral:
• Tele-Savvy
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)
• Tele-Savvy
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each). Videos may be modified after feedback from Prototype arm.

Other:
• iPad
a tablet computer with an internet connection

Locations

Country	Name	City	State
United States	Emory Alzheimer's Disease Research Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants who use at least half of the opportunities (half of the conferences and half of the daily lessons)		6 weeks	No
Secondary	Change in Zarit Burden Interview Score	A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care.	Baseline, 6 weeks	No
Secondary	Change in Center for Epidemiological Studies-Depression Scale Score	A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.	Baseline, 6 weeks	No
Secondary	Change in State Trait Anxiety Index (STAI) Score	State Trait Anxiety Index questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.	Baseline, 6 weeks	No
Secondary	Change in Connor Davidson Resilience Scale (CD-RISC)	The Connor-Davidson Resilience scale (CD-RISC) comprises of 25 items, each rated on a 5-point scale. A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.	Baseline, 6 weeks	No
Secondary	Change in Perceived Stress Scale	The Perceived Stress Scale is a 10-item questionnaire, on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.	Baseline, 6 weeks	No
Secondary	Change in Caregiver Self-Efficacy Score	Caregiver self-efficacy was measured by the Revised Checklist for Caregiving Self-Efficacy; the scale consists of 17 items which are rated from 0 - 100% confidence. The total score is summed from these percentages and ranges from 0 - 1700 where higher scores indicate a higher level of confidence.	Baseline, 6 weeks	No
Secondary	Change in Personal Mastery scale	Personal Mastery scale is a seven item, five-point Likert scale. Scoring is done by summing item scores for a total score (possible range 7-35) with higher scores indicating higher levels of mastery.	Baseline, 6 weeks	No
Secondary	Change in Revised Memory and Behavior Problem Checklist	This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.	Baseline, 6 weeks	No
Secondary	Change in Lawton Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL) Scale	Lawton ADL/IADL is caregiver reported performance of personal and instrumental activities of daily living (ADLs). There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.	Baseline, 6 weeks	No