DementiaCP3DNCT04239924
Community Paramedic Coaching Program for Caregivers and People With Dementia
A study testing Paramedic Coaching in people with Dementia, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Paramedic Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 UW Health staff, paramedic coach, or social service provider.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Paramedic Coaching Program for Caregivers and People With Dementia (CP3D)
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.
Read the detailed description
The intervention is an adaptation of the evidence-based REACH program (Resources Enhancing Alzheimer's Caregiver Health), designed for and validated in multiple settings to give education, tools, and support to informal caregivers of people with dementia, delivered through a series of at-home visits (minimum of 9 in-person and 3 phone sessions) conducted by trained and certified coaches over 6-12 months. The content of the coaching visits will follow the REACH program protocol, with materials customized with information about local community resources (e.g., Dane County).
Coach/administrator training for delivery of the REACH intervention will be conducted by master trainers from the Rosalynn Carter Institute (RCI) for Caregiving, a department of Georgia Southwestern State University, who administers, certifies, and provides oversight for REACH sites nationally (https://www.rosalynncarter.org/programs/rci-reach/). For the purposes of this pilot study, the investigators have coordinated with RCI to extend delivery of REACH content over a 12-month period, with home visits occurring more frequently at the beginning and spreading further apart towards the end, and additional phone "REVIEW" sessions between home-visits.
Each home visit covers specific coaching content, building on strategies and behaviors covered in prior sessions. The program includes flexibility to allow coaches to adapt the timing/delivery of content to attend to the needs of the caregiver (e.g., answering questions about previously-covered topics, covering topics from a future visit to help coach a caregiver through an emergent dementia-related issue). Sessions typically last 1-2 hours. Following each visit, the coach completes a fidelity checklist and writes client progress notes as per the REACH protocol.
This pilot adapts prior REACH implementations in two main ways: (1) intervention coaches will be community paramedics with advanced medical training, rather than social workers (or other non-medical social service personnel), and (2) the program will be formally coordinated with the participant and caregiver's primary care practice, allowing for care coordination and information sharing between participants, coaches, and clinic staff/providers. Participants will also have the ability to share information about their use of community dementia care resources (e.g., social services, transportation, senior center case management, dementia caregiver support groups, dementia-related educational programming, respite) with coaches so they can communicate necessary information to the clinic for possible inclusion in the participant's Electronic Health Record (EHR) (as per the clinic's determination), facilitate care coordination, and help keep the participant's care plan up to date. Paramedic coaches will be utilizing their medical knowledge, but not providing any direct medical care.
This pilot study also differs from prior REACH trials in that outcome measures include health care and emergency services utilization, particularly related to the occurrence of acute medical and behavioral problems, as well as perceptions of health care quality, in addition to caregiver psycho-socio-emotional measures (already included in the standard REACH assessment package).
The study will employ a stepped design using a rapid-cycle evaluation approach. Three cohorts of 4-5 patient-caregiver dyads each will start the intervention at staggered intervals. Within each cohort, a new dyad will begin the program approximately every two weeks, with an approximate four week gap between each cohort for feedback collection and program iteration. Real-time feedback obtained from multiple intervention stakeholders (caregivers, persons with dementia, coaches, clinical staff/providers - up to 10 enrolled) will be used to iteratively improve intervention delivery and program implementation for the next, all while the first group continues the pilot. In this way, problems can be identified and solutions generated, with enough time to adapt the program and evaluate revisions. Staggering participant start dates allows for multiple rapid-cycle iterations within a single pilot study.
NOTE: While COVID-19 restrictions are in place, all feedback interviews will take place by telephone or WebEx videoconferencing, beginning 17 March 2020.
- Conditions
- Dementia
- Being tested
- Paramedic Coaching
- Keywords
- Community Care, Coaching, Paramedic, Caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paramedic CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Paramedic Coaching | Experimental | The intervention is an adaptation of the evidence-based REACH program Receives: Behavioral: Paramedic Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 months
Secondary outcomes (11)
Change in Zarit Burden Interview (ZBI-12) Score
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.
Measured: 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
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.
Measured: Baseline, week 13, week 25, week 50
Change in Center for Epidemiologic Studies Depression Scale (CESD-10)
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.
Measured: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
Change in Revised Caregiving Satisfaction Scale (RCSS)
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.
Measured: Baseline, week 13, week 25, week 50
Change in Revised Scale for Caregiving Self-Efficacy
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.
Measured: First home visit (~ week 1) and last home visit (~up to week 50)
Change in Work-Family Conflict Scale (WFC)
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.
Measured: First home visit (~ week 1) and last home visit (~up to week 50)
Change in Caregiver Quality of Life (C-DEMQOL) Score
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.
Measured: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
Change in Knowledge of Dementia (DKAS) Score
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. The range for score values is 0 to 50, the higher the score the better the outcome (a.k.a. the more knowledgeable about dementia).
Measured: First home visit (~ week 1) and week 13
Clinic Utilization by Persons With Dementia
As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for persons with dementia.
Measured: up to 24 months
Clinic Utilization by Caregivers of Persons With Dementia
As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for caregivers of persons with dementia.
Measured: up to 24 months
Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure
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.
Measured: First home visit (~ week 1) and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start28 Jan 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Manish N Shah, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239924
- Sponsor's protocol ID
- 2019-1218
- Other IDs
- A534100, SMPH/EMERG MED, K24AG054560, Protocol Version 1/20/2021
- Acronym
- CP3D
- Status last verified
- Jul 2023
- First submitted
- 21 Jan 2020
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Paramedic Coaching Program for Caregivers and People With Dementia (CP3D)
- ClinicalTrials.gov ID
- NCT04239924
- Acronym / sponsor ID
- CP3D / 2019-1218
- Conditions
- Dementia
- Keywords
- Community Care, Coaching, Paramedic, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The intervention is an adaptation of the evidence-based REACH program (Resources Enhancing Alzheimer's Caregiver Health), designed for and validated in multiple settings to give education, tools, and support to informal caregivers of people with dementia, delivered through a series of at-home visits (minimum of 9 in-person and 3 phone sessions) conducted by trained and certified coaches over 6-12 months. The content of the coaching visits will follow the REACH program protocol, with materials customized with information about local community resources (e.g., Dane County).
Coach/administrator training for delivery of the REACH intervention will be conducted by master trainers from the Rosalynn Carter Institute (RCI) for Caregiving, a department of Georgia Southwestern State University, who administers, certifies, and provides oversight for REACH sites nationally (https://www.rosalynncarter.org/programs/rci-reach/). For the purposes of this pilot study, the investigators have coordinated with RCI to extend delivery of REACH content over a 12-month period, with home visits occurring more frequently at the beginning and spreading further apart towards the end, and additional phone "REVIEW" sessions between home-visits.
Each home visit covers specific coaching content, building on strategies and behaviors covered in prior sessions. The program includes flexibility to allow coaches to adapt the timing/delivery of content to attend to the needs of the caregiver (e.g., answering questions about previously-covered topics, covering topics from a future visit to help coach a caregiver through an emergent dementia-related issue). Sessions typically last 1-2 hours. Following each visit, the coach completes a fidelity checklist and writes client progress notes as per the REACH protocol.
This pilot adapts prior REACH implementations in two main ways: (1) intervention coaches will be community paramedics with advanced medical training, rather than social workers (or other non-medical social service personnel), and (2) the program will be formally coordinated with the participant and caregiver's primary care practice, allowing for care coordination and information sharing between participants, coaches, and clinic staff/providers. Participants will also have the ability to share information about their use of community dementia care resources (e.g., social services, transportation, senior center case management, dementia caregiver support groups, dementia-related educational programming, respite) with coaches so they can communicate necessary information to the clinic for possible inclusion in the participant's Electronic Health Record (EHR) (as per the clinic's determination), facilitate care coordination, and help keep the participant's care plan up to date. Paramedic coaches will be utilizing their medical knowledge, but not providing any direct medical care.
This pilot study also differs from prior REACH trials in that outcome measures include health care and emergency services utilization, particularly related to the occurrence of acute medical and behavioral problems, as well as perceptions of health care quality, in addition to caregiver psycho-socio-emotional measures (already included in the standard REACH assessment package).
The study will employ a stepped design using a rapid-cycle evaluation approach. Three cohorts of 4-5 patient-caregiver dyads each will start the intervention at staggered intervals. Within each cohort, a new dyad will begin the program approximately every two weeks, with an approximate four week gap between each cohort for feedback collection and program iteration. Real-time feedback obtained from multiple intervention stakeholders (caregivers, persons with dementia, coaches, clinical staff/providers - up to 10 enrolled) will be used to iteratively improve intervention delivery and program implementation for the next, all while the first group continues the pilot. In this way, problems can be identified and solutions generated, with enough time to adapt the program and evaluate revisions. Staggering participant start dates allows for multiple rapid-cycle iterations within a single pilot study.
NOTE: While COVID-19 restrictions are in place, all feedback interviews will take place by telephone or WebEx videoconferencing, beginning 17 March 2020.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paramedic Coaching | Experimental | Behavioral: Paramedic CoachingThe intervention is an adaptation of the evidence-based REACH program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paramedic CoachingThe 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. | Behavioural | Paramedic Coaching |
Primary outcome
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.
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.
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.
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.
11 secondary outcomes
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)
Change in Generalized Anxiety Disorder (GAD-7) Score
Time frame: Baseline, week 13, week 25, week 50
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)
Change in Revised Caregiving Satisfaction Scale (RCSS)
Time frame: Baseline, week 13, week 25, week 50
Change in Revised Scale for Caregiving Self-Efficacy
Time frame: First home visit (~ week 1) and last home visit (~up to week 50)
Change in Work-Family Conflict Scale (WFC)
Time frame: First home visit (~ week 1) and last home visit (~up to week 50)
Change in Caregiver Quality of Life (C-DEMQOL) Score
Time frame: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
Change in Knowledge of Dementia (DKAS) Score
Time frame: First home visit (~ week 1) and week 13
Clinic Utilization by Persons With Dementia
Time frame: up to 24 months
Clinic Utilization by Caregivers of Persons With Dementia
Time frame: up to 24 months
Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure
Time frame: First home visit (~ week 1) and week 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish N Shah, MD, MPH principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paramedic Coaching in people with Dementia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Visits to the Emergency Department by the Person With Dementia (time frame: up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.