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Completed

NCT Number: NCT02300584

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

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).

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Alzheimer's Disease Research Center

Atlanta, Georgia, 30329, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-Savvy

Behavioral

as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)

IPAD

Other

a tablet computer with an internet connection

Primary outcomes

  1. 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 outcomes

  1. Change in Zarit Burden Interview Score

    Time frame: Baseline, 6 weeks

    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.

  2. Change in Center for Epidemiological Studies-Depression Scale Score

    Time frame: Baseline, 6 weeks

    A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.

  3. Change in State Trait Anxiety Index (STAI) Score

    Time frame: Baseline, 6 weeks

    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.

  4. Change in Connor Davidson Resilience Scale (CD-RISC)

    Time frame: Baseline, 6 weeks

    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.

  5. Change in Perceived Stress Scale

    Time frame: Baseline, 6 weeks

    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.

  6. Change in Caregiver Self-Efficacy Score

    Time frame: Baseline, 6 weeks

    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.

  7. Change in Personal Mastery scale

    Time frame: Baseline, 6 weeks

    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.

  8. Change in Revised Memory and Behavior Problem Checklist

    Time frame: Baseline, 6 weeks

    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.

  9. Change in Lawton Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL) Scale

    Time frame: Baseline, 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2014
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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