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Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) (PAACC)

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAACC
REACH-VA
Sponsored by
Salem Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Caregivers will include family members living with the individual diagnosed with Alzheimer's Disease( AD) or Alzheimer's disease related dementia(ADRD) or Traumatic Brain Injury -AD(TBI-AD) with moderate to severe caregiver burden .
  • Care recipients with diagnosis of Diagnosis of AD or ADRD or TBI-related AD .

Exclusion Criteria:

  • Care givers: Determined to be an imminent risk to self or others,the Care recipient currently resides in a nursing home or assisted living facilities, unable to provide their own consent to participate in the study , and active substance use disorder in the last 1yr.
  • Care recipient: Determined to be an imminent risk to self or others, Caregiver is not interested in the study, unable to obtain informed consent from the Care recipient

Sites / Locations

  • VA Boston Health Care system
  • Salem VAMCRecruiting
  • Salem Veteran Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

REACH-VA

PAACC

Arm Description

A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress.

A mindfulness-based multi-component caregiver intervention to reduce caregiver stress.

Outcomes

Primary Outcome Measures

Perceived Stress Scale
The Perceived Stress Scale (PSS) is a 10-item self-report scale developed to measure the degree to which each participant perceives and appraises recent life events as stressful

Secondary Outcome Measures

Full Information

First Posted
February 21, 2018
Last Updated
September 10, 2018
Sponsor
Salem Veterans Affairs Medical Center
Collaborators
VA Boston Healthcare System, Virginia Polytechnic Institute and State University, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03447860
Brief Title
Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)
Acronym
PAACC
Official Title
Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC): A Randomized Controlled Trial on the Effectiveness of a Mindfulness Based Caregiver Multicomponent Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Salem Veterans Affairs Medical Center
Collaborators
VA Boston Healthcare System, Virginia Polytechnic Institute and State University, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Primary objective of the study is to evaluate the effectiveness of mindfulness based caregiver intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) compared to an established cognitive behavior therapy based dementia caregiver intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH) in improving caregiver burden and quality of life of care recipient.
Detailed Description
The study is a randomized controlled trial comparing a mindfulness-enhanced evidence-based caregiver skill-building intervention (PAACC) to REACH-VA to reduce caregiver burden and increase quality of life of the care recipient. For this, caregivers of persons with ADRD or TBI-AD who have moderate to severe burden will be randomly assigned to either receive PAACC or receive REACH-VA. Both the interventions will include 4 biweekly sessions delivered by trained interventionists, followed by an outcome testing session after the intervention. Outcomes of caregiver stress, health and well being will be assessed at baseline and at the end of the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REACH-VA
Arm Type
Active Comparator
Arm Description
A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress.
Arm Title
PAACC
Arm Type
Experimental
Arm Description
A mindfulness-based multi-component caregiver intervention to reduce caregiver stress.
Intervention Type
Behavioral
Intervention Name(s)
PAACC
Intervention Description
Mindfulness based caregiver intervention that includes education , problem solving, skill building, stress management and mindfulness to help enhance compassion and acceptance of self and others
Intervention Type
Behavioral
Intervention Name(s)
REACH-VA
Intervention Description
A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
The Perceived Stress Scale (PSS) is a 10-item self-report scale developed to measure the degree to which each participant perceives and appraises recent life events as stressful
Time Frame
4-6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Caregivers will include family members living with the individual diagnosed with Alzheimer's Disease( AD) or Alzheimer's disease related dementia(ADRD) or Traumatic Brain Injury -AD(TBI-AD) with moderate to severe caregiver burden . Care recipients with diagnosis of Diagnosis of AD or ADRD or TBI-related AD . Exclusion Criteria: Care givers: Determined to be an imminent risk to self or others,the Care recipient currently resides in a nursing home or assisted living facilities, unable to provide their own consent to participate in the study , and active substance use disorder in the last 1yr. Care recipient: Determined to be an imminent risk to self or others, Caregiver is not interested in the study, unable to obtain informed consent from the Care recipient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frances Hickman
Phone
5409822463
Ext
1207
Email
frances.hickman3@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamta Sapra, MD
Organizational Affiliation
Salem VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Health Care system
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Jacobs, PhD
Facility Name
Salem VAMC
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamta Sapra, MD
Phone
540-982-2463
Ext
1453
Email
mamta.sapra@va.gov
First Name & Middle Initial & Last Name & Degree
Tonda Yates, LPN
Phone
5409822463
Ext
1534
Email
tonda.yates@va.gov
Facility Name
Salem Veteran Affairs Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamta Sapra, MD
Phone
540-982-2463
Ext
1453
Email
mamta.sapra@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)

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