Worksite Wellness Within Long-term Care Facilities

December 8, 2025 updated by: Kelly Doran, University of Maryland, Baltimore

The Worksite Heart Health Improvement Project (WHHIP) + Function Focused Care (FFC)

The goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. We also aim to test if increasing wellness behaviors in staff will translate to increased wellness behaviors in residents due to positive role modeling.

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

This is a cluster randomized control trial (initially intended to recruit 246 staff and 180 residents) implemented in six long-term care worksites. Three sites will be randomized to the WHHIP-PLUS & FFC and three sites will be randomized to the education-only.

The intervention occurs over 12 months and measures will be collected at three timepoints. We will test treatment fidelity as well as if our intervention improves Life's Simple 7 scores and reduces stress levels among long-term care workers and increases physical activity among residents.

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.
159

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
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Nursing

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Staff inclusion criteria:

18 years or older; Able to understand and speak English; Employed by the facility; Passed the evaluation to sign consent

Resident inclusion criteria:

55 years or older; Able to understand and speak English; Resident of the facility; Passed the evaluation to sign consent

No exclusion criteria for staff or residents

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: Prevention
  • 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: Education only
Education
Behavioral: Education only control
Education at the start of the project
Experimental: WHHIP-PLUS and Function Focused Care

Component I: Stakeholder Group Involvement:

Component II: Environment Assessment:

Component III: Organizational Changes To Reduce Job Stress:

Component IV- Worker Health Behavior Change including function focused care interventions
Behavioral: WHHIP PLUS
Worksite health promotion and occupational health and safety (total worker health)

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
Cardiovascular disease risk
Time Frame: baseline, 6-months, 12-months
Composite life simple 7 scores and individual scores from life simple 7 components (blood pressure, weight, cholesterol, blood sugar, tobacco exposure, diet, physical activity) for staff
baseline, 6-months, 12-months

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
Short version of the Depression Anxiety Stress Scale-Stress- (DASS-S)
Time Frame: baseline, 6-months, 12-months
Personal mood assessment tool, it can be scored as a composite mood score or three individual subscales, higher indicates more stress, 0-21 for each subscale or 0-63 for the composite for staff
baseline, 6-months, 12-months
Job strain model tool
Time Frame: baseline, 6-months, 12-months
Tool to measure work environment for staff including job control (including decision authority [9 items, range 9-36] and skill discretion [6 items, range 6-24]), job demands (4 items, range 4-16), social support (6 items, range 6-24 ), and organizational justice (5 items, range 5-20). Lower scores are desired.
baseline, 6-months, 12-months

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
Modified Nursing Assistant Self-efficacy for Restorative Care (NASERC)
Time Frame: baseline, 6-months, 12-months
Tool to assess staff encouraging their patients to engage in heart healthy behaviors, range 0-36, higher means more self-efficacy for staff
baseline, 6-months, 12-months
Modified Nursing Assistant Outcome Expectations for Restorative Care (NAOERC)
Time Frame: baseline, 6-months, 12-months
Tool to assess staff encouraging their patients to engage in heart healthy behaviors, range 0-44, higher means more outcome expectations for staff
baseline, 6-months, 12-months
Sleep
Time Frame: baseline, 6-months, 12-months
Accelerometer for staff
baseline, 6-months, 12-months
Bioelectrical Impedance Analysis (BIA)
Time Frame: baseline, 6-months, 12-months
Percent of body fat and muscle mass for staff
baseline, 6-months, 12-months
Modified Pittsburgh Sleep Quality Index
Time Frame: baseline, 6-months, 12-months
Individual items on sleep hours and quality for staff
baseline, 6-months, 12-months
Barthel index
Time Frame: baseline, 6-months, 12-months
Assesses functional independence for residents
baseline, 6-months, 12-months
Function focused care
Time Frame: baseline, 6-months, 12-months
This tool is on observational check list that assesses long-term care staff and resident interactions for encouragement in function focused care (i.e., how staff engage or encourage residents to engage in physical activity). Staff are observed for about 30 minutes and scored (performed, not performed, not observed) on encouragement of function focused care for 19 typical care items such as bed mobility, ambulation in hallway.
baseline, 6-months, 12-months
3 word recall from mini-cog
Time Frame: baseline, 6-months, 12-months
Stating 3 words to residents and asking them to recall them words.
baseline, 6-months, 12-months

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.
University of Maryland, Baltimore

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.
American Heart Association
Building Healthy Behaviors Across the Life Span Research Center

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: Kelly Doran, PhD, RN, UMB

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.
June 28, 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.
October 31, 2024

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.
November 8, 2024

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).
November 5, 2019

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.
November 14, 2019

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.
November 18, 2019

Study Record Updates

Last Update Posted (Estimated)

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.
December 16, 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.
December 8, 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.
November 1, 2024

More Information

Terms related to this study

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.
  • HP-00086939
  • 19TPA34830011 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified raw data

IPD Sharing Time Frame

Once the study and preliminary analysis is complete (anticipated date 2025). Once published it will remain available

IPD Sharing Access Criteria

open

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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