- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05037084
Activity and Health in Nursing Homes
March 29, 2022 updated by: Norwegian University of Science and Technology
The Association Between Physical Behavior, Sleep and Neuropsychiatric Symptoms in Nursing Homes
There is expected to be an increased need for full time nursing homes as the increase in number of older adults increases and the rate of dementia diagnosis happens simultaneous with the decrees of healthcare personnel the years to come.
A lift in knowledge is needed to provide a better and more efficient healthcare to be better equipped to meet this societal challenge.
Physical activity and sleep are important indicators of health, but also on effect of treatment and care for this frail population.
Comprehensive mapping of personnel time spent on different tasks and older adults' physical function throughout a week gives a unique opportunity to gain new knowledge about everyday life in nursing homes.
The main aim of this project is to describe associations between physical behavior, sleep and symptoms in residents in nursing homes in Trondheim Municipality and combine these with personnel time spent on different working tasks.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway
- Trondheim Kommune
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
63 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All residents living full time in nursing homes.
These are often frail older adults with reduced physical function, high number of medications and comorbidities.
Description
Inclusion Criteria:
All residents in nursing homes in Trondheim Municipality.
Exclusion Criteria:
Terminal residents or residents that can not stand or walk a few steps independently.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axivity accelerometer
Time Frame: 7 days
|
Activity monitoring
|
7 days
|
Somnofy sleepmonitor
Time Frame: 7 days
|
Sleep monitoring
|
7 days
|
Short Physical Performance Battery (SPPB)
Time Frame: Baseline
|
Measurement of physical function
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time register
Time Frame: 7 days
|
Time used on different tasks during the work day
|
7 days
|
Neuropsychiatric Inventory (NPI)
Time Frame: Baseline
|
provide a brief assessment of neuropsychiatric symptomatology in routine clinical practice settings
|
Baseline
|
Dementia Staging Instrument (CDR)
Time Frame: Baseline
|
characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Ingrid Olsen, Trondheim Kommune
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2021
Primary Completion (Anticipated)
May 31, 2022
Study Completion (Anticipated)
May 31, 2022
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
August 31, 2021
First Posted (Actual)
September 8, 2021
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 157470
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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