Community Paramedic Coaching Program for Caregivers and People With Dementia

NCT04239924 | Completed Results

• 5 other identifiers: 2019-1218A534100SMPH/EMERG MEDK24AG054560Protocol Version 1/20/2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Community Care; Coaching; Paramedic; Caregivers

Outcome Measures

Primary Outcomes (4)

• Number of Visits to the Emergency Department by the Person With Dementia

  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.

  up to 24 months

• Number of Visits to the Emergency Department by the Caregiver of the Person With Dementia

  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.

  up to 24 months

• Feasibility: Proportion of Coaching Phone Calls Completed

  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.

  up to 12 months

• Feasibility: Proportion of Coaching Home Visits Completed

  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.

  up to 12 months

Secondary Outcomes (11)

• Change in Zarit Burden Interview (ZBI-12) Score

  First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)

• Change in Generalized Anxiety Disorder (GAD-7) Score

  Baseline, week 13, week 25, week 50

• Change in Center for Epidemiologic Studies Depression Scale (CESD-10)

  First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)

• Change in Revised Caregiving Satisfaction Scale (RCSS)

  Baseline, week 13, week 25, week 50

• Change in Revised Scale for Caregiving Self-Efficacy

  First home visit (~ week 1) and last home visit (~up to week 50)

Study Arms (1)

Paramedic Coaching

EXPERIMENTAL

The intervention is an adaptation of the evidence-based REACH program

Behavioral: Paramedic Coaching

Interventions

Paramedic Coaching BEHAVIORAL

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.

Paramedic Coaching

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Manish Shah
• Organization: BerbeeWalsh Department of Emergency Medicine

mnshah@medicine.wisc.edu

608-263-9174

Study Officials

• Manish N Shah, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: January 28, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)