Trial Outcomes & Findings for Community Paramedic Coaching Program for Caregivers and People With Dementia (NCT NCT04239924)

NCT ID: NCT04239924

Last Updated: 2023-08-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: up to 24 months
• Results posted on: 2023-08-01

Participant Flow

20 participant enrolled are 10 caregivers and 10 patients with dementia

Participant milestones

Measure	Paramedic Coaching of Caregivers The intervention is an adaptation of the evidence-based REACH program 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.
Overall Study STARTED	20
Overall Study Caregivers	10
Overall Study Patient With Dementia	10
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Paramedic Coaching of Caregivers The intervention is an adaptation of the evidence-based REACH program 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.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Community Paramedic Coaching Program for Caregivers and People With Dementia

Baseline characteristics by cohort

Measure	Paramedic Coaching n=20 Participants The intervention is an adaptation of the evidence-based REACH program 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.
Age, Continuous	77.1 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Number of Visits to the Emergency Department by the Person With Dementia	15 visits to the Emergency Department

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Number of Visits to the Emergency Department by the Caregiver of the Person With Dementia	1 visits to the Emergency Department

PRIMARY outcome

Timeframe: up to 12 months

Population: The coaching phone calls are relevant to and only conducted with caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=30 Number of Phone Calls Made 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.
Feasibility: Proportion of Coaching Phone Calls Completed	27 Number of Phone Calls Completed

PRIMARY outcome

Timeframe: up to 12 months

Population: The coaching phone calls are relevant to and only conducted with caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=90 Number of Home Visits Planned 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.
Feasibility: Proportion of Coaching Home Visits Completed	82 number of completed coaching visits

SECONDARY outcome

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

Population: This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Change in Zarit Burden Interview (ZBI-12) Score First home visit	13 score on a scale Standard Deviation 9.7
Change in Zarit Burden Interview (ZBI-12) Score Week 13	18.5 score on a scale Standard Deviation 11.7
Change in Zarit Burden Interview (ZBI-12) Score Week 25	15.75 score on a scale Standard Deviation 7.8
Change in Zarit Burden Interview (ZBI-12) Score Week 50	19 score on a scale Standard Deviation NA Unable to obtain standard deviation with sample size of 1. By week 50, we were only able to obtain 1 participant's feedback.

SECONDARY outcome

Timeframe: Baseline, week 13, week 25, week 50

Population: This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Change in Generalized Anxiety Disorder (GAD-7) Score Baseline	7.7 score on a scale Standard Deviation 4.7
Change in Generalized Anxiety Disorder (GAD-7) Score Week 13	5.5 score on a scale Standard Deviation 3.3
Change in Generalized Anxiety Disorder (GAD-7) Score Week 25	5.4 score on a scale Standard Deviation 3.0
Change in Generalized Anxiety Disorder (GAD-7) Score Week 50	4 score on a scale Standard Deviation NA Unable to obtain standard deviation with sample size of 1. By week 50, we were only able to obtain 1 participant's feedback.

SECONDARY outcome

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

Population: This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Change in Center for Epidemiologic Studies Depression Scale (CESD-10) Week 25	7.3 score on a scale Standard Deviation 5.4
Change in Center for Epidemiologic Studies Depression Scale (CESD-10) Week 50	10 score on a scale Standard Deviation NA Unable to obtain standard deviation with sample size of 1. By week 50, we were only able to obtain 1 participant's feedback.
Change in Center for Epidemiologic Studies Depression Scale (CESD-10) First home visit	7.7 score on a scale Standard Deviation 5.7
Change in Center for Epidemiologic Studies Depression Scale (CESD-10) Week 13	8.4 score on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: Baseline, week 13, week 25, week 50

Population: This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Change in Revised Caregiving Satisfaction Scale (RCSS) Baseline	24.1 score on a scale Standard Deviation 3.6
Change in Revised Caregiving Satisfaction Scale (RCSS) Week 13	20.5 score on a scale Standard Deviation 4.1
Change in Revised Caregiving Satisfaction Scale (RCSS) Week 25	22 score on a scale Standard Deviation 4.9
Change in Revised Caregiving Satisfaction Scale (RCSS) Week 50	24 score on a scale Standard Deviation NA Unable to obtain standard deviation with sample size of 1. By week 50, we were only able to obtain 1 participant's feedback.

SECONDARY outcome

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

Population: This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Change in Revised Scale for Caregiving Self-Efficacy Controlling Upsetting Thoughts - last home visit	78.4 score on a scale Standard Deviation 10.6
Change in Revised Scale for Caregiving Self-Efficacy Obtaining Respite - first home visit	65.8 score on a scale Standard Deviation 28.2
Change in Revised Scale for Caregiving Self-Efficacy Obtaining Respite - last home visit	71.6 score on a scale Standard Deviation 18.9
Change in Revised Scale for Caregiving Self-Efficacy Responding to Disruptive Behavior - first home visit	70.4 score on a scale Standard Deviation 11.8
Change in Revised Scale for Caregiving Self-Efficacy Responding to Disruptive Behavior - last home visit	77.6 score on a scale Standard Deviation 12.7
Change in Revised Scale for Caregiving Self-Efficacy Controlling Upsetting Thoughts - first home visit	76.22 score on a scale Standard Deviation 12.7

SECONDARY outcome

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

Population: Survey only relevant to caregivers who are working. Unable to obtain participant feedback for last home visit.

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.

Outcome measures

Measure	Paramedic Coaching n=4 Participants 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.
Change in Work-Family Conflict Scale (WFC) First Home Visit	15 score on a scale Standard Deviation 3.9

SECONDARY outcome

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

Population: This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Change in Caregiver Quality of Life (C-DEMQOL) Score First home visit	20.4 score on a scale Standard Deviation 4.4
Change in Caregiver Quality of Life (C-DEMQOL) Score Week 13	20.4 score on a scale Standard Deviation 4.4
Change in Caregiver Quality of Life (C-DEMQOL) Score Week 25	20.5 score on a scale Standard Deviation 3.7
Change in Caregiver Quality of Life (C-DEMQOL) Score Week 50	19.5 score on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: First home visit (~ week 1) and week 13

Population: This interview is relevant to and only conducted on caregivers

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).

Outcome measures

Measure	Paramedic Coaching n=8 Participants 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.
Change in Knowledge of Dementia (DKAS) Score First home visit	34.3 score on a scale Standard Deviation 3.5
Change in Knowledge of Dementia (DKAS) Score Week 13	35 score on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: up to 24 months

Population: No data was collected. As the outcomes were not relevant to the primary goal of the project, medical records were not abstracted for this data due to study staff changes and time constraints.

As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for persons with dementia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: No data was collected. As the outcomes were not relevant to the primary goal of the project, medical records were not abstracted for this data due to study staff changes and time constraints.

As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for caregivers of persons with dementia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First home visit (~ week 1) and week 13

Population: This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants.

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.

Outcome measures

Measure	Paramedic Coaching n=10 Participants 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.
Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure First home visit	32.3 score on a scale Standard Error 8.8
Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure Week 13	36.6 score on a scale Standard Error 2.4

Adverse Events

Paramedic Coaching

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paramedic Coaching n=20 participants at risk The intervention is an adaptation of the evidence-based REACH program 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.
Vascular disorders Serious Adverse Events	5.0% 1/20 • Number of events 2 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.
Vascular disorders Serious Adverse Event	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.
General disorders Serious Adverse Event	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.

Other adverse events

Measure	Paramedic Coaching n=20 participants at risk The intervention is an adaptation of the evidence-based REACH program 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.
Renal and urinary disorders ED Use	5.0% 1/20 • Number of events 3 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.
Vascular disorders ED Use	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.
Nervous system disorders ED Use	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.
Gastrointestinal disorders ED Use	5.0% 1/20 • Number of events 2 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.
Injury, poisoning and procedural complications ED Use	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.
General disorders ED Use	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months. Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.

Additional Information

Dr. Manish Shah

BerbeeWalsh Department of Emergency Medicine

Phone: 608-263-9174

Email: mnshah@medicine.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place