Clinical trial NCT04166643: Worksite Wellness Within Long-term Care Facilities
Official title: The Worksite Heart Health Improvement Project (WHHIP) + Function Focused Care (FFC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Worksite Health Promotion
Lifestyle Risk Reduction
Cardiovascular Diseases
Occupational Stress
Healthcare Workers
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2019-11-18
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular disease risk
timeFrame: baseline, 6-months, 12-months
Secondary outcomes:
measure: Short version of the Depression Anxiety Stress Scale-Stress- (DASS-S)
timeFrame: baseline, 6-months, 12-months
measure: Job strain model tool
timeFrame: baseline, 6-months, 12-months
Other outcomes:
measure: Modified Nursing Assistant Self-efficacy for Restorative Care (NASERC)
timeFrame: baseline, 6-months, 12-months
measure: Modified Nursing Assistant Outcome Expectations for Restorative Care (NAOERC)
timeFrame: baseline, 6-months, 12-months
measure: Sleep
timeFrame: baseline, 6-months, 12-months
measure: Bioelectrical Impedance Analysis (BIA)
timeFrame: baseline, 6-months, 12-months
measure: Modified Pittsburgh Sleep Quality Index
timeFrame: baseline, 6-months, 12-months
measure: Barthel index
timeFrame: baseline, 6-months, 12-months
measure: Function focused care
timeFrame: baseline, 6-months, 12-months
measure: 3 word recall from mini-cog
timeFrame: baseline, 6-months, 12-months
Locations:
city: Bethesda
country: United States
facility: Maplewood Park Place (Sunrise facility)
state: Maryland
city: Columbia
country: United States
facility: Sunrise of Columbia
state: Maryland
city: Pikesville
country: United States
facility: Sunrise of Pikesville
state: Maryland
city: Severna Park
country: United States
facility: Sunrise Of Severna Park
state: Maryland
city: Silver Spring
country: United States
facility: Sunrise of Silver Spring
state: Maryland
city: Towson
country: United States
facility: Edenwald Senior Living
state: Maryland
Study officials:
affiliation: UMB
name: Kelly Doran, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: