Worksite Wellness Within Long-term Care Facilities

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: Active, not recruiting
• Conditions: Cardiovascular Diseases; Healthcare Workers; Occupational Stress; Lifestyle Risk Reduction; Worksite Health Promotion
• Intervention / Treatment: Behavioral: WHHIP PLUS; Behavioral: Education only control

Detailed Description

This is a cluster randomized control trial (staff n=246 and resident n=180) 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: Interventional
• Enrollment (Estimated): 475
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Doran, PhD, RN; Phone Number: 410-706-5470; Email: kdoran@umaryland.edu

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Maplewood Park Place (Sunrise facility)
    • Columbia, Maryland, United States, 21044
      • Sunrise of Columbia
    • Pikesville, Maryland, United States, 21208
      • Sunrise of Pikesville
    • Severna Park, Maryland, United States, 21146
      • Sunrise Of Severna Park
    • Silver Spring, Maryland, United States, 20904
      • Sunrise of Silver Spring
    • Towson, Maryland, United States, 21286
      • Edenwald Senior Living

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short version of the Depression Anxiety Stress Scale-Stress- (DASS-S)	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	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

Outcome Measure	Measure Description	Time Frame
Modified Nursing Assistant Self-efficacy for Restorative Care (NASERC)	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)	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	Accelerometer for staff	baseline, 6-months, 12-months
Bioelectrical Impedance Analysis (BIA)	Percent of body fat and muscle mass for staff	baseline, 6-months, 12-months
Modified Pittsburgh Sleep Quality Index	Individual items on sleep hours and quality for staff	baseline, 6-months, 12-months
Barthel index	Assesses functional independence for residents	baseline, 6-months, 12-months
Function focused care	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	Stating 3 words to residents and asking them to recall them words.	baseline, 6-months, 12-months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: American Heart Association; University of Maryland, School of Nursing
• Investigators: Principal Investigator: Kelly Doran, PhD, RN, UMB

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Cardiovascular Diseases; Occupational Stress
• Other Study ID 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