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Community Paramedic Coaching Program for Caregivers and People With Dementia (CP3D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239924
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This pilot study is designed to evaluate the potential effectiveness of the implementation strategy and intervention delivery model of a community paramedic coaching program for caregivers of persons with dementia, in direct coordination with the participant and caregiver's primary health care team. Specifically, the acceptability, appropriateness, and feasibility of the program will be assessed, collecting data from all implementation stakeholders at baseline, 13 weeks, 25 weeks, and post-intervention (~50 weeks) using quantitative survey instruments and qualitative interviews.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Paramedic Coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community Paramedic Coaching Program for Caregivers and People With Dementia (CP3D)
Actual Study Start Date : January 28, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Paramedic Coaching
The intervention is an adaptation of the evidence-based REACH program
Behavioral: Paramedic Coaching
The intervention is an adaptation of the evidence-based REACH program, specific coaching content is delivered by paramedics in 1-2 hour in-home sessions and over the phone throughout a 12-month period.




Primary Outcome Measures :
  1. Number of Visits to the Emergency Department by the Person with Dementia [ Time Frame: up to 24 months ]
    As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for persons with dementia.

  2. Number of Visits to the Emergency Department by the Caregiver of the Person with Dementia [ Time Frame: up to 24 months ]
    As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for average older adults.

  3. Feasibility: Proportion of Coaching Phone Calls Completed [ Time Frame: up to 12 months ]
    The intervention will be deemed feasible if at least 75% of the intended coaching phone calls are completed. The minimum number of coaching calls is 3, additional calls will be scheduled opposite weeks of home visits as needed.

  4. Feasibility: Proportion of Coaching Home Visits Completed [ Time Frame: up to 12 months ]
    The intervention will be deemed feasible if at least 75% of the intended home visits are completed. The minimum number of intended home visits is 9.


Secondary Outcome Measures :
  1. Change in Zarit Burden Interview (ZBI-12) Score [ Time Frame: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) ]
    The Zarit Burden Interview measures caregiver burden. This is a 12-item survey with a total possible range of scores from 0-48, where higher scores indicate increased burden. The investigators hypothesize the score will decrease as a result of the intervention.

  2. Change in Generalized Anxiety Disorder (GAD-7) Score [ Time Frame: Baseline, week 13, week 25, week 50 ]
    The GAD-7 is a 7-item survey that measures anxiety symptom severity. The total possible range of scores is 0-21, where higher scores indicate increased symptom severity. The investigators hypothesize the score will decrease as a result of the intervention.

  3. Change in Center for Epidemiologic Studies Depression Scale (CESD-10) [ Time Frame: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) ]
    The CESD-10 is a general measure of depression frequently used in caregiver studies. It is a 10-item survey with a total possible range of scores of 0-30 where higher scores indicate increased depression. The investigators hypothesize the score will decrease as a result of the intervention.

  4. Change in Revised Caregiving Satisfaction Scale (RCSS) [ Time Frame: Baseline, week 13, week 25, week 50 ]
    The RCSS is a 6-item survey used to measure the positive aspects of caring. The range of total possible scores is 6-30 where higher scores indicate increased caregiver satisfaction. The investigators hypothesize the score will increase as a result of the intervention.

  5. Change in Revised Scale for Caregiving Self-Efficacy [ Time Frame: First home visit (~ week 1) and last home visit (~up to week 50) ]
    The revised scale for caregiving self-efficacy measures three domains: obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts. It is a 15-item scale with a total possible range of scores between 0-100, where higher scores are better. The investigators hypothesize the score will increase as a result of the intervention.

  6. Change in Work-Family Conflict Scale (WFC) [ Time Frame: First home visit (~ week 1) and last home visit (~up to week 50) ]
    WFC is measured for the caregiver. It is a 6-item survey with a total possible range of scores between 6-30 with higher scores indicating lesser work-family conflict. The investigators hypothesize the score will increase as a result of the intervention.

  7. Change in Caregiver Quality of Life (C-DEMQOL) Score [ Time Frame: Baseline and 62 weeks (12 weeks post completion) ]
    C-DEMQOL is measured for the caregiver. The investigators will be asking 18 of the questions from the scale to understand the quality of life the caregivers experience. Scores can range from 18-90, with a higher score reflecting a higher quality of life.

  8. Change in Knowledge of Dementia (DKAS) Score [ Time Frame: Baseline and 62 weeks (12 weeks post completion) ]
    DKAS is measured for the caregiver. It is a 25 item true-false survey of facts about dementia. Scoring is by measuring the proportion of questions answered correctly.

  9. Clinic Utilization by Persons with Dementia [ Time Frame: up to 24 months ]
    As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for persons with dementia.

  10. Clinic Utilization by Caregivers of Persons with Dementia [ Time Frame: up to 24 months ]
    As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for caregivers of persons with dementia.

  11. Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure [ Time Frame: Baseline and 62 weeks (12 weeks post completion) ]
    Assesses caregivers perception of communication with health care team and extent to which the team considers their capacity and preferences in decision making. This measure consists of 12 questions, with scores ranging from 12-60, where higher scores indicate increased communication with the health care team.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient Inclusion Criteria:

  • Diagnosis or indication in medical record of mild to moderate dementia (any subtype)
  • English speaking
  • Community-dwelling (independent and assisted living acceptable)
  • Living with their primary informal caregiver
  • Patient of a UW Health primary care provider affiliated with and participating in the study

Patient Exclusion Criteria:

  • Receiving intensive care management services
  • Receiving aggressive care for another condition (e.g., chemotherapy for cancer, surgery planned for problem)
  • In isolation due to contagious illness
  • Enrolled in home hospice
  • Currently incarcerated, in police custody, or ward of the state
  • Legally blind or deaf (unable to hear or see even with assistive devices)
  • Lacks decisional capacity and no available legally authorized representative (LAR) to provide consent
  • Patient refuses enrollment

Caregiver Inclusion Criteria:

  • Adult informal caregiver (≥18 years old) of a person eligible for this study (determination based upon caregiver self-identification).
  • Lives in the same household (primary residence) as the patient with dementia.
  • Has a working telephone
  • English speaking
  • UW Health primary care provider

Caregiver Exclusion Criteria:

  • Unable to participate in the program as defined
  • Employed by a professional/private agency to provide care to the care recipient (i.e., professional caregiver, not an informal caregiver)
  • Has a diagnosis of dementia or cognitive impairment causing functional impairment
  • In isolation due to contagious illness
  • Legally blind or deaf (unable to hear or see even with assistive devices)
  • Refuses enrollment

Stakeholder Inclusion Criteria:

  • Involved in the implementation study activities in related to the intervention, either as a clinician, member of the clinical staff, paramedic coach, or social service provider.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239924


Contacts
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Contact: Manish N Shah, MD, MPH 608-890-7187 mnshah@medicine.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Manish N Shah, MD, MPH    608-890-7187    mnshah@medicine.wisc.edu   
Principal Investigator: Manish N Shah, MD, MPH         
Principal Investigator: Gwen Jacobsohn, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Manish N Shah, MD, MPH University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04239924    
Other Study ID Numbers: 2019-1218
A534100 ( Other Identifier: UW Madison )
SMPH/EMERG MED ( Other Identifier: UW Madison )
K24AG054560 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Community Care
Coaching
Paramedic
Caregivers
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders