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History of Changes for Study: NCT02463708
Evaluation of the PACE/PACENET BHL Caregiver Program (CREST)
Latest version (submitted August 30, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 2, 2015 None (earliest Version on record)
2 October 4, 2015 Groups and Interventions, Study Design, Study Description, Eligibility and Study Status
3 June 24, 2017 Study Status and IPDSharing
4 February 22, 2019 Study Status and Contacts/Locations
5 March 12, 2020 Study Status and Sponsor/Collaborators
6 March 22, 2021 Study Status
7 August 20, 2021 Study Status, Outcome Measures and References
8 August 30, 2022 Study Status
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Study NCT02463708
Submitted Date:  June 2, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 819012
Brief Title: Evaluation of the PACE/PACENET BHL Caregiver Program (CREST)
Official Title: Evaluation of the PACE/PACENET BHL Caregiver Outreach and Telehealth Education Program
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2015
Overall Status: Enrolling by invitation
Study Start: November 2013
Primary Completion: June 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: June 2, 2015
First Submitted that
Met QC Criteria:
June 2, 2015
First Posted: June 4, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 2, 2015
Last Update Posted: June 4, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Pennsylvania
Responsible Party: Principal Investigator
Investigator: David Oslin
Official Title: Professor of Psychiatry, Department of Psychiatry, Perelman School of Medicine
Affiliation: University of Pennsylvania
Collaborators: Magellan Health Services
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This project will conduct a retrospective clinical database review and a one-time research interview to evaluate outcomes among a sub-set of caregivers (CGs) who were enrolled in the Behavioral Health Laboratory (BHL) Caregiver Outreach and Telehealth Education Program (COTP). The investigators will recruit CGs whose CRs met criteria for clinically significant cognitive impairment and/or dementia and who received care management services through the BHL COTP.
Detailed Description:

The PACE/PACENET BHL Caregiver Outreach and Telehealth Program (BHL COTP) was developed in an effort to address and minimize barriers to successful care management of a growing number of community-dwelling older adults. This research project seeks to evaluate the feasibility, acceptability, and individual-level outcomes of a subset of participants engaged in the COPT program. Specifically, the investigators will examine the impact of the COPT program on the functioning and wellbeing of participating cognitively impaired PACE/PACENET beneficiaries and their informal CGs.

Retrospective clinical program data on PACE/PACENET BHL COTP beneficiaries and the CGs collected at intake (i.e., baseline), over the course of care management, and at program termination (i.e., approximately 3 months following intake) will be extracted from clinical databases for program evaluation purposes. The researchers will use data collected during the clinical program to evaluate CR and CG characteristics, self-reported needs, care participation, and predictors of improved outcomes at 3 and 6 months.

A single follow-up research evaluation will be conducted at 6 months post intake. This the 6 month follow-up research interviews will evaluate the extent to which a clinical care management program (BHL COTP) for older adults with clinically significant cognitive impairment and/or dementia and the CGs, 1) facilitates access to and the use of medical and social services, and 2) improves CR (e.g., behavioral symptoms, delayed nursing home placement) and CG (e.g., CG mastery, burden, affect) outcomes.

Open or close this module Conditions
Conditions: Dementia
Keywords: Care Giver
Dementia
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Retrospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 350 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Retrospective Chart Review
A retrospective chart review of data collected during BHL COTP participation (i.e., at baseline and follow up interviews) for caregivers whose care recipients met criteria for clinically significant cognitive impairment and/or dementia and who received care management services.
Behavioral: BHL COPT
The BHL COTP starts with an initial baseline assessment; following the baseline assessment, it is then divided into several core services. CG receive care management services, which includes contact, support, and active listening, as well as written material regarding caregiving and dementia and referral to appropriate community services. CGs also are offered the Telehealth Education Program (TEP) a manualized program developed to provide both education and psychosocial support for individuals caring for older adults with clinically significant cognitive impairment/dementia.
6 Month Outcome Evaluation
A one-time research interview (6 Month Outcome Evaluation) for caregivers who participated in the BHL COTP and who provide verbal consent.
Behavioral: BHL COPT
The BHL COTP starts with an initial baseline assessment; following the baseline assessment, it is then divided into several core services. CG receive care management services, which includes contact, support, and active listening, as well as written material regarding caregiving and dementia and referral to appropriate community services. CGs also are offered the Telehealth Education Program (TEP) a manualized program developed to provide both education and psychosocial support for individuals caring for older adults with clinically significant cognitive impairment/dementia.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Revised Memory and Behavior Problems Checklist
[ Time Frame: 1 year ]

A checklist for dementia-related symptoms in 3 domains (memory impairment, depression, and disruptive behaviors) and associated CG burden.
Secondary Outcome Measures:
1. Lawton Caregiver Appraisal Scales
[ Time Frame: 1 year ]

A scale for caregiver satisfaction, mastery, demands, and perceived impact.
2. Desire to Institutionalize Scale
[ Time Frame: 1 year ]

A 6-item scale predictive of CGs actual institutionalization of care recipients.
Open or close this module Eligibility
Study Population: Caregivers of PACE/PACENET beneficiaries who are participating in the BHL COTP.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Aged 18 and older, males and females.
  2. The beneficiary screened positive for clinically significant cognitive impairment (BOMC score > 14) during the Care Recipient BL BHL COTP interview and agreed to allow COPT staff to speak with a CG, OR, the beneficiary could not complete the Care Recipient BL BHL COTP interview at all, agreed to allow COPT staff to speak with a CG on their behalf, and the CG verified that the beneficiary has clinically significant cognitive impairment (via AD8 score of 2 or more) and/or a dementia diagnosis made by a health care provider.
  3. CG provides verbal informed consent to the use of retrospective clinical BHL COTP data and participation in the 6 Month Outcome Research Evaluation at the completion of the 3 Month Program Termination visit.

Exclusion Criteria:

  • Not meeting the inclusion criteria listed above.
Open or close this module Contacts/Locations
Study Officials: David Oslin, MD
Principal Investigator
University of Pennsylvania
Locations: United States, Pennsylvania
Department of Psychiatry (Addictions/Geriatric), University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Wray LO, Shulan MD, Toseland RW, Freeman KE, Vasquez BE, Gao J. The effect of telephone support groups on costs of care for veterans with dementia. Gerontologist. 2010 Oct;50(5):623-31. doi: 10.1093/geront/gnq040. Epub 2010 May 27. PubMed 20507926
Links:
Available IPD/Information:

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