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Evaluation of the PACE/PACENET BHL Caregiver Program (CREST)

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ClinicalTrials.gov Identifier: NCT02463708
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2015
Last Update Posted : August 31, 2022
Sponsor:
Collaborator:
Magellan Health Services
Information provided by (Responsible Party):
Shahrzad Mavandadi, PhD, University of Pennsylvania

Tracking Information
First Submitted Date June 2, 2015
First Posted Date June 4, 2015
Last Update Posted Date August 31, 2022
Study Start Date November 2013
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2021)
Revised Memory and Behavior Problems Checklist [ Time Frame: 6 Months ]
A checklist for dementia-related symptoms in 3 domains (memory impairment, depression, and disruptive behaviors) and associated CG burden.
Original Primary Outcome Measures
 (submitted: June 2, 2015)
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.
Change History
Current Secondary Outcome Measures
 (submitted: August 20, 2021)
  • Lawton Caregiver Appraisal Scales [ Time Frame: 6 Months ]
    A scale for caregiver satisfaction, mastery, demands, and perceived impact.
  • Desire to Institutionalize Scale [ Time Frame: 6 Months ]
    A 6-item scale predictive of CGs actual institutionalization of care recipients.
Original Secondary Outcome Measures
 (submitted: June 2, 2015)
  • Lawton Caregiver Appraisal Scales [ Time Frame: 1 year ]
    A scale for caregiver satisfaction, mastery, demands, and perceived impact.
  • Desire to Institutionalize Scale [ Time Frame: 1 year ]
    A 6-item scale predictive of CGs actual institutionalization of care recipients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the PACE/PACENET BHL Caregiver Program
Official Title Evaluation of the PACE/PACENET BHL Caregiver Outreach and Telehealth Education Program
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 Care Recipients (CR) met criteria for clinically significant cognitive impairment and/or dementia and who received care management services through the COTP.
Detailed Description

The University of Pennsylvania's Caregiver Resources, Education, & SupporT (CREST) Program seeks to improve the overall quality of life and wellbeing of older PACE/PACENET beneficiaries (or care recipients (CRs)) with cognitive impairment and their caregivers (CGs). Specifically, the program provides education, support, and services to both beneficiaries and CGs of PACE/PACENET beneficiaries who have filled a prescription for medication used to treat cognitive impairment. Many of these beneficiaries also meet criteria for clinically significant cognitive impairment/dementia. Thus, the level of contact and services varies as a function of reported needs and symptoms.

The CREST Program developed the BHL Caregiver Outreach and Telehealth Program (COTP) in an effort to address and minimize barriers to successful care management of a growing number of community-dwelling older adults. The COTP starts with an initial baseline assessment; following the baseline assessment, it is then divided into several core services. CGs 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.

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 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 baseline. This the 6 month follow-up research interviews will evaluate the extent to which a clinical care management program (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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Caregivers of PACE/PACENET beneficiaries who are participating in the BHL COTP.
Condition Dementia
Intervention Behavioral: BHL COTP
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.
Study Groups/Cohorts BHL COTP Caregivers
Caregivers participate in the BHL COTP, which provides support, education, and care management services from a Behavioral Health Provider (BHP) in addition to the Telehealth Education Program (TEP), a manualized program that consists of various modules that seek to provide both education and psychosocial support for individuals caring for older adults with clinically significant cognitive impairment/dementia.
Intervention: Behavioral: BHL COTP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 2, 2015)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility 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 Baseline BHL COTP interview and agreed to allow COPT staff to speak with a CG, OR, the beneficiary could not complete the Care Recipient Baseline 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02463708
Other Study ID Numbers 819012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Shahrzad Mavandadi, PhD, University of Pennsylvania
Original Responsible Party David Oslin, University of Pennsylvania, Professor of Psychiatry, Department of Psychiatry, Perelman School of Medicine
Current Study Sponsor University of Pennsylvania
Original Study Sponsor Same as current
Collaborators Magellan Health Services
Investigators
Study Director: Shahrzad Mavandadi, PhD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date August 2022