Mobile Tablet Education to Advance Caregiver Health (MTEACHing)
|ClinicalTrials.gov Identifier: NCT03417219|
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : July 15, 2019
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Behavioral: Education and Skill Building Rehabilitation-mobile (ESBR-m) Behavioral: Usual Care (UC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|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|
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").
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417219
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA|
|Palo Alto, California, United States, 94304-1290|
|Principal Investigator:||Blake K Scanlon, PhD||VA Palo Alto Health Care System, Palo Alto, CA|