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Worksite Wellness Within Long-term Care Facilities

Primary Purpose

Worksite Health Promotion, Lifestyle Risk Reduction, Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WHHIP PLUS
Education only control
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Worksite Health Promotion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maplewood Park Place (Sunrise facility)
  • Sunrise of Columbia
  • Sunrise of Pikesville
  • Sunrise Of Severna Park
  • Sunrise of Silver Spring
  • Edenwald Senior Living

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Education only

WHHIP-PLUS and Function Focused Care

Arm Description

Education

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Modified Whitehall Job Characteristics Questionnaire
Tool, measures, control (range 0-45 or can be split into 2 further subscales), demands (range 0-12), and support (range 0-27) for staff

Full Information

First Posted
November 5, 2019
Last Updated
September 12, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland, School of Nursing, American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT04166643
Brief Title
Worksite Wellness Within Long-term Care Facilities
Official Title
The Worksite Heart Health Improvement Project (WHHIP) + Function Focused Care (FFC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland, School of Nursing, American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Worksite Health Promotion, Lifestyle Risk Reduction, Cardiovascular Diseases, Occupational Stress, Healthcare Workers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
475 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education only
Arm Type
Active Comparator
Arm Description
Education
Arm Title
WHHIP-PLUS and Function Focused Care
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
WHHIP PLUS
Intervention Description
Worksite health promotion and occupational health and safety (total worker health)
Intervention Type
Behavioral
Intervention Name(s)
Education only control
Intervention Description
Education at the start of the project
Primary Outcome Measure Information:
Title
Cardiovascular disease risk
Description
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
Time Frame
baseline, 6-months, 12-months
Secondary Outcome Measure Information:
Title
Short version of the Depression Anxiety Stress Scale-Stress- (DASS-S)
Description
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
Time Frame
baseline, 6-months, 12-months
Title
Modified Whitehall Job Characteristics Questionnaire
Description
Tool, measures, control (range 0-45 or can be split into 2 further subscales), demands (range 0-12), and support (range 0-27) for staff
Time Frame
baseline, 6-months, 12-months
Other Pre-specified Outcome Measures:
Title
Modified Nursing Assistant Self-efficacy for Restorative Care (NASERC)
Description
Tool to assess staff encouraging their patients to engage in heart healthy behaviors, range 0-36, higher means more self-efficacy for staff
Time Frame
baseline, 6-months, 12-months
Title
Modified Nursing Assistant Outcome Expectations for Restorative Care (NAOERC)
Description
Tool to assess staff encouraging their patients to engage in heart healthy behaviors, range 0-44, higher means more outcome expectations for staff
Time Frame
baseline, 6-months, 12-months
Title
Sleep
Description
Accelerometer for staff
Time Frame
baseline, 6-months, 12-months
Title
Bioelectrical Impedance Analysis (BIA)
Description
Percent of body fat and muscle mass for staff
Time Frame
baseline, 6-months, 12-months
Title
Modified Pittsburgh Sleep Quality Index
Description
Individual items on sleep hours and quality for staff
Time Frame
baseline, 6-months, 12-months
Title
Barthel index
Description
Assesses functional independence for residents
Time Frame
baseline, 6-months, 12-months
Title
Function focused care
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
3 word recall from mini-cog
Description
Stating 3 words to residents and asking them to recall them words.
Time Frame
baseline, 6-months, 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Doran, PhD, RN
Organizational Affiliation
UMB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maplewood Park Place (Sunrise facility)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Sunrise of Columbia
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Sunrise of Pikesville
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Sunrise Of Severna Park
City
Severna Park
State/Province
Maryland
ZIP/Postal Code
21146
Country
United States
Facility Name
Sunrise of Silver Spring
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Edenwald Senior Living
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Worksite Wellness Within Long-term Care Facilities

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