Patient-Centered Dementia Care Practice Coaching Intervention (DCPR_CC3)

May 19, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
449

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60601
        • Alzheimer's Association

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Coaching Group
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:
  • Organization-Wide Coaching Intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alzheimer's Disease and Related Disorders Association, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings