- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06421246
Implementation and Evaluation of Real Time Monitoring of Physical Activity in Geriatric Patients - a Hybrid Implementation and Effectiveness Study in Two Patient Cohorts
Physical Activity in Geriatric Patients Before and After the Introduction of a Staff-facing Real-time Activity Screen and Validation of the Danish Version of the Acute Care Mobility Assessment - a Hybrid Implementation and Effectiveness Study in Two Patient Cohorts
The study aim to assess 24-hour activity during hospitalization in older adults admitted to a geriatric ward and to validate the Danish version of the Acute Care Mobility Assessment.
In a follow-up study, we will implement and evaluate a staff-facing activity screen showing real-time physical activity in the geriatric ward with a focus on changes in staff culture (awareness and actions) and basis for data-driven discussions about physical activity during hospitalization inspired by Making Every Contact Count. Also, we will reassess in-hospital physical activity in older adults admitted to the geriatric ward.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study uses a Hybrid Type I design in which both the implementation of a staff-facing screen and the effectiveness on physical activity will be evaluated. The study is conducted in two phases.
Phase one is an observational cohort study. During 6 weeks, 24-hour activity will be assessed in all patients (65+) admitted to a geriatric ward in Denmark, who are able to walk and to provide informed consent (or vicarious consent). Activity will be measured for a maximum of 7 days. Demographic characteristics will be collected (sex, age, place of residence, comorbidities, admission diagnosis, civil status, frailty), and the patients will be asked about their: daily activities, walking ability, life space activity, present activity, use of walking aids, and falls. On inclusion, the patients will be assessed for their basic mobility, cognition, gait speed, and their level of mobility. The Acute Care Mobility Assessment will be validated on the initial 5-10 patients via cognitive debriefing interviews (May-July 2024). In the same period, an ethnographic field study will be conducted with focus on physical activity followed by semi-structured interviews (N=17) with managers and health care professionals.
In the follow-up study, we will assess in-hospital physical activity over a 6-week period after introducing a staff-facing activity screen, showing real-time activity and to investigate whether the activity screen increases physical activity among hospitalized geriatric patients. 24-hours physical activity will be re-quantified using SENS motion ®, sensor technology. The study design will otherwise follow the same approach as the initial study, including the use of the same outcome measures. In the same period, we will repeat the ethnographic field study and interviews regarding focus on physical activity and implementation of the activity screen with managers and health care professionals inspired by Making Every Contact Count. The Consolidated Framework for Implementation Research (CFIR) will be used as Framework, and focus will be on adoption and adaptation.
The study meets the guidelines of the Declaration of Helsinki and is approved by the Research Ethics Committee (F-24023831).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hvidovre, Denmark, 2650
- Copenhagen University Hospital, Hvidovre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 65 years
- no delirium
- ability to ambulate
Exclusion Criteria:
- in isolation
- teminally ill
- Expected to be discharged within 24-hours from inclusion
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Activity monitoring and validity of the Danish Version of the Acute Care Mobility Assessement
24- hour activity will be assessed by SENS motion acitivity monitors before (Cohort 1) and after the introduction (Cohort 2) of a screen-solution with staff-facing real time activity data and investigation of the implementation process and outcomes.
Furthermore, the Acute Care mobility assessment will be validated by cognitive debriefing interviews in 5-10 patients in Cohort 1.
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Activity will be monitored before and after the introduction of a staff-facing screen
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily steps
Time Frame: 7 days
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Number of daily steps taken and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported mobility
Time Frame: Days 2, 4 and 6 after inclusion
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Self-reported mobility by the Acute Care Mobility Assessment.
A score of 0-12 can be obtained, with 0 reflecting poor mobility and 12 reflecting a high level of mobility.
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Days 2, 4 and 6 after inclusion
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Frailty
Time Frame: At inclusion
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By the Clinical Frailty Scale, which is a clinical evaluation of the degree of frailty of a person.
It is scored by health care professionals on a scale from 1 (very fit) to 9 (terminally ill)
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At inclusion
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Cognitive status
Time Frame: At inclusion
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By the Orientation Memory Concentration Test, which is a screening of cognitive function.
A score from 0 to 28 i obtained with lower scores reflecting poorer cognition (0-7: highly impaired; 8-17 points: moderately imparied; 18-24 points: mildly impaired; 25-28 points: no or insignificatn impairment).
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At inclusion
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Basic mobility
Time Frame: Days 2, 4 and 6 after inclusion
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By the The Cummulated Ambulation Score, which assessed the ability of a person to get in an out of bed, sit to stand from a chair and walk.
It is scored from 0 to 6 with 0 reflecting inability to perform the 3 activities and a score of 6 refelcting independence in the three activities.
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Days 2, 4 and 6 after inclusion
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Highest level of mobility
Time Frame: At inclusion
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By the Johns Hopkins Higest Level of Mobility Scale which evaluates a patient's level of mobiltiy on a 1 (lying) to 8 (waling more than 250 feet) point scale
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At inclusion
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Gait speed
Time Frame: At inclusion
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By the 4 meter habitual gait speed test.
It assesses the patient's habitual gait speed on a 4-meter course.
The test is scored in m/s.
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At inclusion
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Life Space mobility
Time Frame: At inclusion, 4 weeks post discharge
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By the Life Space Assessment-DK, which measure mobility and level of dependence in mobility.
A score of 0-120 can be obtained, with 0 reflecting poor mobility and 120 reflecting high mobility.
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At inclusion, 4 weeks post discharge
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Self-reported pre-admission (2 weeks prior to admission) and post discharge mobility
Time Frame: At inclusion and 1 week after discharge
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By the New Mobility Score, which assesses the ability to walk indoors and outdoors and the ability to go shopping.
A score from 0-9 can be obtained, with 0 reflecting low mobility and 9 reflecting high mobility.
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At inclusion and 1 week after discharge
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Activities of daily living
Time Frame: At inclusion and 1 week after discharge
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By the Katz index, which assesses independence in 6 Activities of Daily Living on a scale from 0 to 6 with 0 reflecting dependence in all activities and 6 reflecting independence in all activities.
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At inclusion and 1 week after discharge
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Uptime
Time Frame: 7 days
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Daily time spent in uptime and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
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7 days
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Daily walking
Time Frame: 7 days
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Daily time spent walking and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
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7 days
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Daily standing
Time Frame: 7 days
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Daily time spent walking assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
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7 days
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Daily lying/sitting
Time Frame: 7 days
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Daily time spent sitting/lying and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
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7 days
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Readmission
Time Frame: 3 months after discharge
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Number of readmission with three months after discharge
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3 months after discharge
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Falls
Time Frame: 1 month after discharge
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Number of falls within the first month after discharge.
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1 month after discharge
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F-24023831
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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