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

Primary Purpose

Dementia, Alzheimer's Disease, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-Savvy
Tele-Savvy
iPad
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Alzheimer's Disease Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prototype Program

Field Program

Arm Description

The Savvy Caregiver (Savvy) - program delivered on an iPad (a tablet computer with an internet connection) extends over a six week period. Caregivers are asked to view brief daily videos (8-12 minutes) on the iPad. Once each week, a group of caregivers joins in a videoconference (an hour) with one or two trained leaders to review material from the week and to learn new material.

The Savvy Caregiver (Savvy) - program delivered on an iPad (a tablet computer with an internet connection) extends over a six week period. Caregivers are asked to view brief daily videos (8-12 minutes) on the iPad. Based on the feedback from the prototype program, the videos may vary. Once each week, a group of caregivers joins in a videoconference (an hour) with one or two trained leaders to review material from the week and to learn new material.

Outcomes

Primary Outcome Measures

The number of participants who use at least half of the opportunities (half of the conferences and half of the daily lessons)

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 21, 2014
Last Updated
September 7, 2016
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02300584
Brief Title
Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program
Official Title
Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer's Disease, Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prototype Program
Arm Type
Experimental
Arm Description
The Savvy Caregiver (Savvy) - program delivered on an iPad (a tablet computer with an internet connection) extends over a six week period. Caregivers are asked to view brief daily videos (8-12 minutes) on the iPad. Once each week, a group of caregivers joins in a videoconference (an hour) with one or two trained leaders to review material from the week and to learn new material.
Arm Title
Field Program
Arm Type
Experimental
Arm Description
The Savvy Caregiver (Savvy) - program delivered on an iPad (a tablet computer with an internet connection) extends over a six week period. Caregivers are asked to view brief daily videos (8-12 minutes) on the iPad. Based on the feedback from the prototype program, the videos may vary. Once each week, a group of caregivers joins in a videoconference (an hour) with one or two trained leaders to review material from the week and to learn new material.
Intervention Type
Behavioral
Intervention Name(s)
Tele-Savvy
Intervention Description
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)
Intervention Type
Behavioral
Intervention Name(s)
Tele-Savvy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
iPad
Intervention Description
a tablet computer with an internet connection
Primary Outcome Measure Information:
Title
The number of participants who use at least half of the opportunities (half of the conferences and half of the daily lessons)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Zarit Burden Interview Score
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in Center for Epidemiological Studies-Depression Scale Score
Description
A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Time Frame
Baseline, 6 weeks
Title
Change in State Trait Anxiety Index (STAI) Score
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in Connor Davidson Resilience Scale (CD-RISC)
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in Perceived Stress Scale
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in Caregiver Self-Efficacy Score
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in Personal Mastery scale
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in Revised Memory and Behavior Problem Checklist
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in Lawton Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL) Scale
Description
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.
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Hepburn, Ph.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Alzheimer's Disease Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

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

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