Mobile Tablet Education to Advance Caregiver Health

NCT03417219 | Completed Results

• 2 other identifiers: E1710-P1I21RX001710
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Caregivers; Family; Veterans; Alzheimer Disease; Memory

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, 4 month follow-up

• 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.

  Baseline, 4 month follow-up

• 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.

  Baseline, 4 month follow-up

Study Arms (2)

Mobile Media Education and Skill-Building Rehabilitation Int

EXPERIMENTAL

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)

Usual Care

ACTIVE COMPARATOR

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)

Interventions

Education and Skill Building Rehabilitation-mobile (ESBR-m) BEHAVIORAL

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.

Mobile Media Education and Skill-Building Rehabilitation Int

Usual Care (UC) BEHAVIORAL

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").

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \-- 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

You may not qualify if:

• \-- 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Blake Scanlon
• Organization: VA Palo Alto Health Care System

blake.scanlon@va.gov

6504935000

Study Officials

• Blake K Scanlon, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 31, 2018
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2018
• Last Updated: July 15, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-01

Locations

US (1)