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Mobile Tablet Education to Advance Caregiver Health (MTEACHing)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and Skill Building Rehabilitation-mobile (ESBR-m)
Usual Care (UC)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Caregivers, Family, Veterans, Alzheimer Disease, Memory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-- Participants must:

  • report distress associated with being the primary caregiver for a family member with dementia
  • reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined
  • provide at least 7 hours of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members)
  • cohabitate with a Veteran diagnosed with dementia
  • be proficient in spoken and written English
  • be capable of providing informed consent

Exclusion Criteria:

-- Potential participants will be screened and excluded for:

  • current or lifetime history of any psychiatric disorder with psychotic features
  • prominent suicidal or homicidal ideation
  • having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months
  • presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation
  • diagnosis of probable or possible dementia
  • a Telephone Cognitive Screen score of < 20
  • participation in another caregiver intervention study within the past year
  • lack of access to telephone and internet services in the home
  • illness that would prevent study participation
  • planned transfer of care receiver to another caregiver or nursing home within 6 months
  • currently living with an implantable cardioverter defibrillator or pacemaker
  • known pregnancy at time of consent

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Media Education and Skill-Building Rehabilitation Int

Usual Care

Arm Description

The investigators' ESBR-m intervention consists of four, 90-minute group (= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.

Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").

Outcomes

Primary Outcome Measures

Change From Baseline Zarit Burden Interview (ZBI) at 4 Months
The Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden. Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers. Scores for each item range from 0 (never) to 4 (nearly always) on questions such as "Do you feel embarrassed by your relative's behavior?." Total scores are calculated by summing all responses and range from 0-88. A higher score is indicative of a worse outcome.
Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months
The Center for Epidemiological Studies-Depression (CES-D) is a 20-item, self-report measure of frequency of depressive symptoms over a one week period. The CES-D is frequently used to assess depression in dementia caregivers and has been shown to be sensitive to changes in caregiver depression post intervention. Scores for each item range from 0 (rarely or none of the time) to 3 (most or all of the time), with some items reverse coded. Total scores are calculated by summing all responses and range from 0-60. A higher score is indicative of a worse outcome.
Change From Baseline Perceived Stress Scale (PSS) at 4 Months
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. We use a 14 item version of the PSS with a minimum score of 0 and a maximum score of 56. Lower values indicate lower perceived stress while higher values indicate higher perceived stress.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2018
Last Updated
April 24, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03417219
Brief Title
Mobile Tablet Education to Advance Caregiver Health
Acronym
MTEACHing
Official Title
Mobile Media Intervention for Family Caregivers of Veterans With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To address the high burden of caring for a Veteran with dementia, the investigators propose to study the effect of a low-cost, rehabilitative intervention for family caregivers of Veterans with dementia. The investigators' novel approach will use mobile media technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers. If this rehabilitative intervention proves successful, it may represent an approach to Veteran and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.
Detailed Description
The proposed project studies the effects of an education and skill-building rehabilitation intervention, designed to be low-cost and clinically translatable through mobile media devices (i.e., tablets), on family caregivers of Veterans with dementia. Intervention effects will be examined longitudinally at baseline and 3 months post-intervention. Advanced statistical techniques will be used to determine the impact of the intervention on: quality of life in caregivers of Veterans with dementia (Aim 1), perceived stress and depressive symptoms in caregivers (Aim 2), and socialization and engagement in pleasant activities in caregivers (Aim 3). If this rehabilitative intervention proves successful, it may represent an approach to Veteran- and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Caregivers, Family, Veterans, Alzheimer Disease, Memory

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Media Education and Skill-Building Rehabilitation Int
Arm Type
Experimental
Arm Description
The investigators' ESBR-m intervention consists of four, 90-minute group (= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
Intervention Type
Behavioral
Intervention Name(s)
Education and Skill Building Rehabilitation-mobile (ESBR-m)
Intervention Description
Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care (UC)
Intervention Description
Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
Primary Outcome Measure Information:
Title
Change From Baseline Zarit Burden Interview (ZBI) at 4 Months
Description
The Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden. Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers. Scores for each item range from 0 (never) to 4 (nearly always) on questions such as "Do you feel embarrassed by your relative's behavior?." Total scores are calculated by summing all responses and range from 0-88. A higher score is indicative of a worse outcome.
Time Frame
Baseline, 4 month follow-up
Title
Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months
Description
The Center for Epidemiological Studies-Depression (CES-D) is a 20-item, self-report measure of frequency of depressive symptoms over a one week period. The CES-D is frequently used to assess depression in dementia caregivers and has been shown to be sensitive to changes in caregiver depression post intervention. Scores for each item range from 0 (rarely or none of the time) to 3 (most or all of the time), with some items reverse coded. Total scores are calculated by summing all responses and range from 0-60. A higher score is indicative of a worse outcome.
Time Frame
Baseline, 4 month follow-up
Title
Change From Baseline Perceived Stress Scale (PSS) at 4 Months
Description
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. We use a 14 item version of the PSS with a minimum score of 0 and a maximum score of 56. Lower values indicate lower perceived stress while higher values indicate higher perceived stress.
Time Frame
Baseline, 4 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -- Participants must: report distress associated with being the primary caregiver for a family member with dementia reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined provide at least 7 hours of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members) cohabitate with a Veteran diagnosed with dementia be proficient in spoken and written English be capable of providing informed consent Exclusion Criteria: -- Potential participants will be screened and excluded for: current or lifetime history of any psychiatric disorder with psychotic features prominent suicidal or homicidal ideation having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation diagnosis of probable or possible dementia a Telephone Cognitive Screen score of < 20 participation in another caregiver intervention study within the past year lack of access to telephone and internet services in the home illness that would prevent study participation planned transfer of care receiver to another caregiver or nursing home within 6 months currently living with an implantable cardioverter defibrillator or pacemaker known pregnancy at time of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blake K Scanlon, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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