Worksite Wellness Within Long-term Care Facilities

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04166643
• Other study ID #: HP-00086939
• Secondary ID: 19TPA34830011
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 475
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Healthcare Workers
• Lifestyle Risk Reduction
• Occupational Stress
• Worksite Health Promotion

Intervention

Behavioral:
• WHHIP PLUS
Worksite health promotion and occupational health and safety (total worker health)
• Education only control
Education at the start of the project

Locations

Country	Name	City	State
United States	Maplewood Park Place (Sunrise facility)	Bethesda	Maryland
United States	Sunrise of Columbia	Columbia	Maryland
United States	Sunrise of Pikesville	Pikesville	Maryland
United States	Sunrise Of Severna Park	Severna Park	Maryland
United States	Sunrise of Silver Spring	Silver Spring	Maryland
United States	Edenwald Senior Living	Towson	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	American Heart Association, University of Maryland, School of Nursing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Sleep	Accelerometer for staff	baseline, 6-months, 12-months
Other	Bioelectrical Impedance Analysis (BIA)	Percent of body fat and muscle mass for staff	baseline, 6-months, 12-months
Other	Modified Pittsburgh Sleep Quality Index	Individual items on sleep hours and quality for staff	baseline, 6-months, 12-months
Other	Barthel index	Assesses functional independence for residents	baseline, 6-months, 12-months
Other	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
Other	3 word recall from mini-cog	Stating 3 words to residents and asking them to recall them words.	baseline, 6-months, 12-months
Primary	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	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
Secondary	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