- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06249204
Patient-Centered Dementia Care Practice Coaching Intervention (DCPR_CC3)
February 12, 2024 updated by: Alzheimer's Disease and Related Disorders Association, Inc
Organization-Wide Coaching Intervention of Dementia Care Practice Recommendations: A Cluster Randomized-Control Trial
The goal of this clinical trial is to compare staff outcomes in long-term care communities who participate in the intervention versus those who do not.
The main questions it aims to answer are: 1.
Is employee satisfaction impacted by the intervention and 2. Is dementia care confidence impacted by the intervention.
Participants will include monthly coaching visits for the intervention group and completion of surveys pre, immediately post and three-months post.
Researchers will compare the intervention group to the control group to see if the intervention impacted the outcomes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Over a six-month coaching program period, staff members from care communities work with a coach to assess their current level of adoption of Dementia Care Practice Recommendations (DCPR) (published recommendations by Alzheimer's Association) and prioritize areas of need /focus.
Teams meet with the coach virtually or in person for 1 hour each month during the six months.
Through an action planning and implementation process, care communities are guided to make organization-wide, measurable changes in the areas of (1) policies and procedures, (2) education and training, and/or (3) care practices to increase and maintain person-centered care practices as outlined in the DCPR.
Coaches provide ongoing support to the care community through telephone and email support between meetings.
Control group will not receive any coaching intervention but receive monthly email (e.g., newsletter about Alzheimer's Association but not related to outcomes) from coaches for check-in.
Alzheimer's Association (AA) hires coaches in study areas based on their skills, experiences, interests and enthusiasm.
Each coach identifies and invites long-term care (i.e., nursing home and assisted living) communities using existing relationships between the AA Chapter and those communities.
In addition, AA staff will work with a national and/or state-wide networking group /association, as well as the Association's Dementia Care Provider Round Tables.
The investigators will also pull the list of nursing homes in the study areas from publicly available data (e.g., Definitive Healthcare).
Once each care community is selected and has agreed to participate, DCPR coaches will request that the care community identify 4-6 staff members to serve on a Care Team.
The consented care communities are randomly assigned to either a control or intervention group (1: 1 block randomization).
Study Type
Interventional
Enrollment (Estimated)
480
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lorna Prophater, MS
- Phone Number: 937-610-7005
- Email: lprophater@alz.org
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60601
- Recruiting
- Alzheimer's Association
-
Contact:
- Lorna Prophater, MS
- Phone Number: 937-610-7005
- Email: lprophater@alz.org
-
Principal Investigator:
- Sam Fazio, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Licensed skilled nursing facilities
- Licensed assisted living facilities
- Located in the state of Ohio
Exclusion Criteria:
- Under the age of 18
- Without documented endorsement for participation from facility leadership
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Coaching Group
The intervention group will be exposed to six coaching sessions (one a month for 6 months) as well as a nine month touch point to complete the 3-month post survey.
This group will have access to a care community coach, resources and use these supports to create action steps towards adopting and implementing person-centered best practices based on an initial self-assessment of their current practices.
|
Over a six-month coaching program period, staff members from care communities work with a coach to assess their current level of adoption of Dementia Care Practice Recommendations (DCPR) (published recommendations by Alzheimer's Association) and prioritize areas of need /focus.
Teams meet with the coach virtually or in person for 1 hour each month during the six months.
Through an action planning and implementation process, care communities are guided to make organization-wide, measurable changes in the areas of (1) policies and procedures, (2) education and training, and/or (3) care practices to increase and maintain person-centered care practices as outlined in the DCPR.
Coaches provide ongoing support to the care community through telephone and email support between meetings.
Other Names:
|
No Intervention: Training Group
This group will complete the same pre, immediate post and 3-month post surveys as the intervention group but will receive no intervention during the six month period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Employee Satisfaction
Time Frame: pre, immediately post, and 3-month post
|
Employee satisfaction was measured using the Centers for Medicare & Medicaid Services (CMS)'s Nursing Home Employee Satisfaction Survey.
This tool contains 5 topic areas, including job satisfaction (9 items), team building and communication (10 items), scheduling and staffing (4 items), training (6 items), and management and leadership (6 items).
Participants will answer on a scale from 1 (strongly disagree) to 5 (strongly agree).
Average score overall and by topic areas will be calculated (range = 1 - 5), where a higher score indicates greater employee satisfaction.
|
pre, immediately post, and 3-month post
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dementia care confidence
Time Frame: pre, immediately post, and 3-month post
|
Dementia care confidence is measured using the Confidence in Dementia Scale (CODES) The nine-item self-report questionnaire is scored on a 5-point scale with anchored ratings of 'not able', 'slightly able', 'somewhat able', 'mostly able', 'very able'.
Total score ranges from 9 to 45, with a higher score signifying better confidence in working with people with dementia.
|
pre, immediately post, and 3-month post
|
Person-centered practices
Time Frame: pre, immediately post, and 3-month post.
|
Person-centered practices are measured using the Toolkit for Person-Centeredness in Assisted Living (workplace practices, individualized care and services, and caregiver-resident relationships domains).
From this tool, three areas will be measured, including workplace practices (23 items), individualized care and services (8 items), and caregiver-resident relationships domains (7 items).
Participants will answer on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree).
Average score overall and by areas will be calculated, and then multiply the average scores by 25.
Total scores overall and by areas range between 25 and 100, with a higher score representing more person-centeredness.
|
pre, immediately post, and 3-month post.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Staff Turnover
Time Frame: Monthly, from the month pre-intervention to 3 months after completion of the intervention (9 times)
|
Turnover rates are assessed monthly from pre-intervention to 3 months after completion of the intervention (9 times) for direct care staff (i.e., certified nursing assistants (CNAs), care aids and other equivalent, front-line care staff), health and social services staff (i.e., registered nurses (RNs), licensed practical nurses (LPNs), social services, activities staff), and leadership staff (i.e., directors of nursing, unit leaders, licensed administrators).
Turnover rates (%) are calculated using the National Nursing Home Quality Improvement Campaign Staff Stability Tracking Tool v2.2, dividing the number terminated as of the last day of the month by the number employed as of the first day of the month.
|
Monthly, from the month pre-intervention to 3 months after completion of the intervention (9 times)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sam Fazio, PhD, Alzheimer's Association
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2022
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
January 11, 2024
First Submitted That Met QC Criteria
February 6, 2024
First Posted (Actual)
February 8, 2024
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC3 - OH_Phase_3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on Coaching Group
-
Aava MedicalUniversity of Helsinki; Finnish Institute for Health and Welfare; Finnish Institute...UnknownBurnout | Metabolic Syndrome | Lipid Metabolism Disorders | Work Related Stress | Lifestyle Risk ReductionFinland
-
McGill University Health Centre/Research Institute...Quebec Breast Cancer FoundationNot yet recruiting
-
Centre Hospitalier Universitaire de Saint EtienneCompletedSleep Apnea SyndromeFrance
-
Emory UniversityUniversity of Colorado, Denver; Children's Healthcare of AtlantaRecruiting
-
Health Resources and Services Administration (HRSA)University of Pennsylvania; University of California, Davis; University of Rochester and other collaboratorsCompleted
-
University of California, Los AngelesActive, not recruiting
-
Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH)CompletedAnorexia Nervosa | Atypical Anorexia NervosaUnited States
-
Duke UniversityNational Institute on Aging (NIA)Active, not recruitingPhysical Activity | Cardiac Rehabilitation | Health CoachingUnited States
-
Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...Completed
-
West German Center of Diabetes and HealthCompleted