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Mobile Tablet Education to Advance Caregiver Health (MTEACHing)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417219
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Education and Skill Building Rehabilitation-mobile (ESBR-m) Behavioral: Usual Care (UC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mobile Media Intervention for Family Caregivers of Veterans With Dementia
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Mobile Media Education and Skill-Building Rehabilitation Int
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.
Behavioral: Education and Skill Building Rehabilitation-mobile (ESBR-m)
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.

Active Comparator: Usual Care
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").
Behavioral: Usual Care (UC)
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 Measures :
  1. Change From Baseline Zarit Burden Interview (ZBI) at 4 Months [ Time Frame: Baseline, 4 month follow-up ]
    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.

  2. Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months [ Time Frame: Baseline, 4 month follow-up ]
    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.

  3. Change From Baseline Perceived Stress Scale (PSS) at 4 Months [ Time Frame: Baseline, 4 month follow-up ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03417219


Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Blake K Scanlon, PhD VA Palo Alto Health Care System, Palo Alto, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Statistical Analysis Plan  [PDF] March 3, 2014
Study Protocol  [PDF] August 21, 2014

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03417219    
Other Study ID Numbers: E1710-P
1I21RX001710 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2018    Key Record Dates
Results First Posted: July 15, 2019
Last Update Posted: July 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by VA Office of Research and Development:
Caregivers
Family
Veterans
Alzheimer Disease
Memory
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders