Caregiver Stress, Dementia, Quality of Life
Conditions
Brief summary
The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers. The main aims are to: * Develop and refine HBPC Dementia Care Quality at Home * Establish feasibility (primary outcome), acceptability, and fidelity of HBPC Dementia Care Quality at Home through an open-pilot trial involving two HBPC practices. Trained clinicians and staff at two HBPC practices will implement the intervention Relevant stakeholders (caregivers of PLWD, and HBPC clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention.
Detailed description
The overarching goal of this project is to develop a dementia care intervention for PLWD and their caregivers, Dementia Care Quality at Home, and test the feasibility of implementing the intervention in two HBPC practices to ultimately improve outcomes of PLWD and their caregivers. The investigators will evaluate the feasibility, acceptability, and fidelity in implementing HBPC Dementia Care Quality at Home in two practices for persons living with dementia and their caregivers through an open pilot. Hypothesis: HBPC Dementia Care Quality at Home will meet benchmarks of feasibility, acceptability, and fidelity by the HBPC practices implementing it and by caregivers of PLWD who experience the intervention. The investigators will assess feasibility of caregivers of PLWD to engage with the intervention, the acceptability of the intervention to caregivers, and the impact of the intervention on caregiver well-being by surveying caregivers at the conclusion of the pilot. In addition, the investigators will assess feasibility, acceptability, and fidelity of the intervention in the practices.
Interventions
OTHERDementia Care Quality at Home
Each of the two HBPC practices will identify at least two trained Dementia Care Quality at Home Champions who will be trained in the intervention comprised of 1) a standardized assessment tool to assess PLWD and caregiver needs; 2) six modules created to optimize the well-being of the PLWD and their caregiver; and 3) regular team-based review of persons participating in the program to address care challenges and a team-based case conference approach to solve these challenges.
Sponsors
Retirement Research Foundation
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A live open-pilot trial will be conducted of the HBPC Dementia Care Quality at Home intervention in two HBPC practices.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Caregiver participants will: * be adults (18 years or older) * have English fluency and literacy * live in the United States * live with and care for an individual with Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD) * anticipate providing care for the next 6 months * provide an average 4 hours of supervision or direct assistance per day for the care recipient and * have been identified by the practice as experiencing caregiver stress. Staff participants will: * be 18 years or older * have English fluency and literacy and live in the United States and * be part of a HBPC primary care program or closely connected to the practice.
Exclusion criteria
* Participants under the age 18. * Participants who have no English fluency and literacy and do not live in the United States. * For caregiver participants, not caring for and living with a patient that is part of a HBPC primary care program or closely connected to the practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility for the Caregiver to Engage With and Complete Baseline Assessments. | Baseline | The percentage of identified caregivers who complete baseline assessments. |
| Feasibility for the Caregiver to Access Educational Materials and Community Resources. | Post-intervention (6 months) | Percent of caregivers will report using 1 or more materials provided by the practice. |
| Feasibility for the Practice of Identifying Potential Patients/Caregivers | Baseline | Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice |
| Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads. | Baseline | Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress). |
| Feasibility for the Practice to Use Baseline Assessments. | Post-intervention (6 months) | Percent of practice personnel who conduct assessments that rate assessments as feasible to use |
| Feasibility for the Practice to Complete Baseline Assessments | Post-intervention (6 months) | The percent of audited assessments that are completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference. | Post-intervention (6 months) | % of case conferences conducted with at least one staff member present from each site |
| Feasibility for the Practice of Recruiting Patient/Caregiver Dyads | Pre-intervention | Percentage of eligible dyads who enroll. |
| Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited. | Pre-intervention (baseline) | Percentage of eligible dyads who enroll who are racial and ethnic minorities. |
| Acceptability of the Intervention to Caregivers to Participate in the Intervention. | Pre-intervention (baseline) | Percent of caregivers invited to participate who agree to participate in the intervention. |
| Patient Quality of Life | Pre-Intervention (baseline) and post-intervention (6 months) | Quality of Life in Alzheimer's Disease. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL. |
| Heard and Understood | Post Intervention (6 months) | A one-item measure of caregivers who report that they felt heard and understood by the practice. |
| Caregivers - Net Promoter Score of Intervention | Post-intervention (6 months) | The single question - How likely are you to recommend X to a friend \[or colleague\]? is rated from 0 - Not at all likely to 10 - Extremely likely. |
| Feasibility for the Practice to Use Care Modules. | Post-intervention (6 months) | The percentage that rates modules as feasible to use. The percentage of practice personnel who complete the modules that rate the modules as feasible to use |
| Feasibility for the Practice to Complete Care Modules | Post Intervention (6-months) | Percent of audited modules that are completed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dementia Care Quality at Home Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Dementia Care Quality at Home |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 13 |
| Care Ecosystem Caregiver Self-Efficacy Score | 8 units on a scale STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Hours Spent Caregiving per week | 88 hours per week STANDARD_DEVIATION 60 |
| Patient Health Questionnaire 8 Item Score | 5 units on a scale STANDARD_DEVIATION 4 |
| Quality of Life in Alzheimer's Disease | 26 units on a scale STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 50 participants |
| Role of Caregiver Adult Child | 27 Participants |
| Role of Caregiver Facility Caregiver | 9 Participants |
| Role of Caregiver Niece | 3 Participants |
| Role of Caregiver Private Paid Caregiver | 3 Participants |
| Role of Caregiver Sibling | 1 Participants |
| Role of Caregiver Spouse/Partner | 7 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 11 Participants |
| The Neuropsychiatric Inventory Questionnaire: Distress Score | 14 units on a scale STANDARD_DEVIATION 12 |
| The Neuropsychiatric Inventory Questionnaire: Severity Score | 10 units on a scale STANDARD_DEVIATION 7 |
| Zarit Burden Interview Score | 16 units on a scale STANDARD_DEVIATION 11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 21 |
| other Total, other adverse events | 0 / 50 | 0 / 21 |
| serious Total, serious adverse events | 0 / 50 | 0 / 21 |
Outcome results
Primary
Feasibility for the Caregiver to Access Educational Materials and Community Resources.
Percent of caregivers will report using 1 or more materials provided by the practice.
Time frame: Post-intervention (6 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Caregiver to Access Educational Materials and Community Resources. | 50 Participants |
Primary
Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.
The percentage of identified caregivers who complete baseline assessments.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Caregiver to Engage With and Complete Baseline Assessments. | 50 Participants |
Primary
Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.
Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).
Time frame: Baseline
Population: % of practice staff that agree or strongly agree that it was easy for our practice to generate a list of persons living with dementia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads. | 18 Participants |
Primary
Feasibility for the Practice of Identifying Potential Patients/Caregivers
Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice
Time frame: Baseline
Population: % of practice staff that agree or strongly agree that it was easy for our practice to generate a list of persons living with dementia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice of Identifying Potential Patients/Caregivers | 18 Participants |
Primary
Feasibility for the Practice to Complete Baseline Assessments
The percent of audited assessments that are completed.
Time frame: Post-intervention (6 months)
Population: 75% of audited assessments will be completed
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice to Complete Baseline Assessments | 7 assessments |
Primary
Feasibility for the Practice to Use Baseline Assessments.
Percent of practice personnel who conduct assessments that rate assessments as feasible to use
Time frame: Post-intervention (6 months)
Population: \> 75% practice personnel who conduct assessments will agree or strongly agree that assessments were feasible to use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice to Use Baseline Assessments. | 18 Participants |
Secondary
Acceptability of the Intervention to Caregivers to Participate in the Intervention.
Percent of caregivers invited to participate who agree to participate in the intervention.
Time frame: Pre-intervention (baseline)
Population: The number of participants analyzed is greater than 50, as 80 is the number of dyads that were eligible for the study and invited to participate, 50 out of 80 enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Acceptability of the Intervention to Caregivers to Participate in the Intervention. | 50 Participants |
Secondary
Caregivers - Net Promoter Score of Intervention
The single question - How likely are you to recommend X to a friend \[or colleague\]? is rated from 0 - Not at all likely to 10 - Extremely likely.
Time frame: Post-intervention (6 months)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dementia Care Quality at Home | Caregivers - Net Promoter Score of Intervention | 8.8 score on a scale |
Secondary
Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.
% of case conferences conducted with at least one staff member present from each site
Time frame: Post-intervention (6 months)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference. | 25 case conferences attended |
Secondary
Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.
Percentage of eligible dyads who enroll who are racial and ethnic minorities.
Time frame: Pre-intervention (baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited. | 26 Participants |
Secondary
Feasibility for the Practice of Recruiting Patient/Caregiver Dyads
Percentage of eligible dyads who enroll.
Time frame: Pre-intervention
Population: The number of participants analyzed is greater than 50 as 80 is the number of dyads that were eligible for the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice of Recruiting Patient/Caregiver Dyads | 50 Participants |
Secondary
Feasibility for the Practice to Complete Care Modules
Percent of audited modules that are completed.
Time frame: Post Intervention (6-months)
Population: \> 50% of audited modules will be completed
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice to Complete Care Modules | 11 modules |
Secondary
Feasibility for the Practice to Use Care Modules.
The percentage that rates modules as feasible to use. The percentage of practice personnel who complete the modules that rate the modules as feasible to use
Time frame: Post-intervention (6 months)
Population: \> 75% practice personnel who complete the modules will rate the modules as feasible or very feasible to use \> 50% of audited modules will be completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Feasibility for the Practice to Use Care Modules. | 18 Participants |
Secondary
Heard and Understood
A one-item measure of caregivers who report that they felt heard and understood by the practice.
Time frame: Post Intervention (6 months)
Population: % of caregivers who report that they felt heard and understood quite a bit or completely by the practice
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dementia Care Quality at Home | Heard and Understood | 37 Participants |
Secondary
Patient Quality of Life
Quality of Life in Alzheimer's Disease. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
Time frame: Pre-Intervention (baseline) and post-intervention (6 months)
Population: Quality of Life in Alzheimer's Disease score Pre and Post-Intervention
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dementia Care Quality at Home | Patient Quality of Life | QoL-AD Pre-Intervention | 25.5 score on a scale |
| Dementia Care Quality at Home | Patient Quality of Life | QoL-AD Post-Intervention | 28.5 score on a scale |