Dementia
Conditions
Keywords
Community Care, Coaching, Paramedic, Caregivers
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.
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.
Interventions
BEHAVIORALParamedic 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.
Sponsors
National Institute on Aging (NIA)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Visits to the Emergency Department by the Person With Dementia | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Revised Scale for Caregiving Self-Efficacy | 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. |
| Change in Work-Family Conflict Scale (WFC) | 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. |
| Change in Caregiver Quality of Life (C-DEMQOL) Score | First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) | 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. |
| 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) | 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. |
| Clinic Utilization by Persons With Dementia | 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. |
| Clinic Utilization by Caregivers of Persons With Dementia | 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. |
| Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure | First home visit (~ week 1) and week 13 | 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. |
| Change in Knowledge of Dementia (DKAS) Score | First home visit (~ week 1) and week 13 | 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). |
| Change in Generalized Anxiety Disorder (GAD-7) Score | 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. |
| 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) | 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. |
| Change in Revised Caregiving Satisfaction Scale (RCSS) | 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. |
Countries
United States
Participant flow
Recruitment details
20 participant enrolled are 10 caregivers and 10 patients with dementia
Participants by arm
| Arm | Count |
|---|---|
| Paramedic Coaching 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Paramedic Coaching |
|---|---|
| Age, Continuous | 77.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 7 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paramedic Coaching | Feasibility: Proportion of Coaching Home Visits Completed | 82 number of completed coaching visits |
Primary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paramedic Coaching | Feasibility: Proportion of Coaching Phone Calls Completed | 27 Number of Phone Calls Completed |
Primary
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.
Time frame: up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paramedic Coaching | Number of Visits to the Emergency Department by the Caregiver of the Person With Dementia | 1 visits to the Emergency Department |
Primary
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.
Time frame: up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paramedic Coaching | Number of Visits to the Emergency Department by the Person With Dementia | 15 visits to the Emergency Department |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | 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 |
| Paramedic Coaching | Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure | Week 13 | 36.6 score on a scale | Standard Error 2.4 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | Change in Caregiver Quality of Life (C-DEMQOL) Score | First home visit | 20.4 score on a scale | Standard Deviation 4.4 |
| Paramedic Coaching | Change in Caregiver Quality of Life (C-DEMQOL) Score | Week 13 | 20.4 score on a scale | Standard Deviation 4.4 |
| Paramedic Coaching | Change in Caregiver Quality of Life (C-DEMQOL) Score | Week 25 | 20.5 score on a scale | Standard Deviation 3.7 |
| Paramedic Coaching | Change in Caregiver Quality of Life (C-DEMQOL) Score | Week 50 | 19.5 score on a scale | Standard Deviation 4 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | Change in Center for Epidemiologic Studies Depression Scale (CESD-10) | First home visit | 7.7 score on a scale | Standard Deviation 5.7 |
| Paramedic Coaching | Change in Center for Epidemiologic Studies Depression Scale (CESD-10) | Week 13 | 8.4 score on a scale | Standard Deviation 4.5 |
| Paramedic Coaching | Change in Center for Epidemiologic Studies Depression Scale (CESD-10) | Week 25 | 7.3 score on a scale | Standard Deviation 5.4 |
| Paramedic Coaching | Change in Center for Epidemiologic Studies Depression Scale (CESD-10) | Week 50 | 10 score on a scale | — |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | Change in Generalized Anxiety Disorder (GAD-7) Score | Week 25 | 5.4 score on a scale | Standard Deviation 3 |
| Paramedic Coaching | Change in Generalized Anxiety Disorder (GAD-7) Score | Baseline | 7.7 score on a scale | Standard Deviation 4.7 |
| Paramedic Coaching | Change in Generalized Anxiety Disorder (GAD-7) Score | Week 13 | 5.5 score on a scale | Standard Deviation 3.3 |
| Paramedic Coaching | Change in Generalized Anxiety Disorder (GAD-7) Score | Week 50 | 4 score on a scale | — |
Secondary
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).
Time frame: First home visit (~ week 1) and week 13
Population: This interview is relevant to and only conducted on caregivers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | Change in Knowledge of Dementia (DKAS) Score | First home visit | 34.3 score on a scale | Standard Deviation 3.5 |
| Paramedic Coaching | Change in Knowledge of Dementia (DKAS) Score | Week 13 | 35 score on a scale | Standard Deviation 5.6 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | Change in Revised Caregiving Satisfaction Scale (RCSS) | Baseline | 24.1 score on a scale | Standard Deviation 3.6 |
| Paramedic Coaching | Change in Revised Caregiving Satisfaction Scale (RCSS) | Week 13 | 20.5 score on a scale | Standard Deviation 4.1 |
| Paramedic Coaching | Change in Revised Caregiving Satisfaction Scale (RCSS) | Week 25 | 22 score on a scale | Standard Deviation 4.9 |
| Paramedic Coaching | Change in Revised Caregiving Satisfaction Scale (RCSS) | Week 50 | 24 score on a scale | — |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | 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 |
| Paramedic Coaching | 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 |
| Paramedic Coaching | Change in Revised Scale for Caregiving Self-Efficacy | Obtaining Respite - first home visit | 65.8 score on a scale | Standard Deviation 28.2 |
| Paramedic Coaching | Change in Revised Scale for Caregiving Self-Efficacy | Obtaining Respite - last home visit | 71.6 score on a scale | Standard Deviation 18.9 |
| Paramedic Coaching | Change in Revised Scale for Caregiving Self-Efficacy | Controlling Upsetting Thoughts - first home visit | 76.22 score on a scale | Standard Deviation 12.7 |
| Paramedic Coaching | Change in Revised Scale for Caregiving Self-Efficacy | Controlling Upsetting Thoughts - last home visit | 78.4 score on a scale | Standard Deviation 10.6 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | Change in Work-Family Conflict Scale (WFC) | First Home Visit | 15 score on a scale | Standard Deviation 3.9 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paramedic Coaching | Change in Zarit Burden Interview (ZBI-12) Score | First home visit | 13 score on a scale | Standard Deviation 9.7 |
| Paramedic Coaching | Change in Zarit Burden Interview (ZBI-12) Score | Week 13 | 18.5 score on a scale | Standard Deviation 11.7 |
| Paramedic Coaching | Change in Zarit Burden Interview (ZBI-12) Score | Week 25 | 15.75 score on a scale | Standard Deviation 7.8 |
| Paramedic Coaching | Change in Zarit Burden Interview (ZBI-12) Score | Week 50 | 19 score on a scale | — |
Secondary
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.
Time frame: 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.
Secondary
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.
Time frame: 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.