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

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ClinicalTrials.gov Identifier: NCT02300584
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Kenneth Hepburn, Emory University

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).

Condition or disease Intervention/treatment Phase
Dementia Alzheimer's Disease Depression Behavioral: Tele-Savvy Other: iPad Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program
Study Start Date : November 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Experimental: Prototype Program
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.
Behavioral: Tele-Savvy
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)

Other: iPad
a tablet computer with an internet connection

Experimental: Field Program
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.
Behavioral: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300584


Locations
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United States, Georgia
Emory Alzheimer's Disease Research Center
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Kenneth Hepburn, Ph.D. Emory University

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Responsible Party: Kenneth Hepburn, Kenneth Hepburn PhD, Emory University
ClinicalTrials.gov Identifier: NCT02300584     History of Changes
Other Study ID Numbers: IRB00074715
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders