NCT04166643

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
2.6 years until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2024

Completed
Last Updated

December 16, 2025

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

November 5, 2019

Last Update Submit

December 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular disease risk

    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 Outcomes (2)

  • Short version of the Depression Anxiety Stress Scale-Stress- (DASS-S)

    baseline, 6-months, 12-months

  • Job strain model tool

    baseline, 6-months, 12-months

Other Outcomes (8)

  • Modified Nursing Assistant Self-efficacy for Restorative Care (NASERC)

    baseline, 6-months, 12-months

  • Modified Nursing Assistant Outcome Expectations for Restorative Care (NAOERC)

    baseline, 6-months, 12-months

  • Sleep

    baseline, 6-months, 12-months

  • +5 more other outcomes

Study Arms (2)

Education only

ACTIVE COMPARATOR

Education

Behavioral: Education only control

WHHIP-PLUS and Function Focused Care

EXPERIMENTAL

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

Interventions

WHHIP PLUSBEHAVIORAL

Worksite health promotion and occupational health and safety (total worker health)

WHHIP-PLUS and Function Focused Care

Education at the start of the project

Education only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Nursing

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Risk Reduction BehaviorCardiovascular DiseasesOccupational Stress

Condition Hierarchy (Ancestors)

BehaviorOccupational DiseasesStress, PsychologicalBehavioral Symptoms

Study Officials

  • Kelly Doran, PhD, RN

    UMB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 18, 2019

Study Start

June 28, 2022

Primary Completion

October 31, 2024

Study Completion

November 8, 2024

Last Updated

December 16, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

De-identified raw data

Time Frame
Once the study and preliminary analysis is complete (anticipated date 2025). Once published it will remain available
Access Criteria
open

Locations