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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
First received
Last updated
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
Health authority
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

Study Design


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
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