Implementation and Evaluation of Real Time Monitoring of Physical Activity in Geriatric Patients - a Hybrid Implementation and Effectiveness Study in Two Patient Cohorts

March 17, 2026 updated by: Mette Merete Pedersen, Copenhagen University Hospital, Hvidovre

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

Completed

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

Observational

Enrollment (Actual)

100

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

      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital, Hvidovre

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Older adults admitted to a geriatric ward at Copenhagen University Hospital, Hvidovre

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Activity will be monitored before and after the introduction of a staff-facing screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily steps
Time Frame: 7 days
Number of daily steps taken and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported mobility
Time Frame: Days 2, 4 and 6 after inclusion
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.
Days 2, 4 and 6 after inclusion
Frailty
Time Frame: At inclusion
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)
At inclusion
Cognitive status
Time Frame: At inclusion
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).
At inclusion
Basic mobility
Time Frame: Days 2, 4 and 6 after inclusion
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.
Days 2, 4 and 6 after inclusion
Highest level of mobility
Time Frame: At inclusion
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
At inclusion
Gait speed
Time Frame: At inclusion
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.
At inclusion
Life Space mobility
Time Frame: At inclusion, 4 weeks post discharge
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.
At inclusion, 4 weeks post discharge
Self-reported pre-admission (2 weeks prior to admission) and post discharge mobility
Time Frame: At inclusion and 1 week after discharge
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.
At inclusion and 1 week after discharge
Activities of daily living
Time Frame: At inclusion and 1 week after discharge
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.
At inclusion and 1 week after discharge
Uptime
Time Frame: 7 days
Daily time spent in uptime and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
7 days
Daily walking
Time Frame: 7 days
Daily time spent walking and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
7 days
Daily standing
Time Frame: 7 days
Daily time spent walking assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
7 days
Daily lying/sitting
Time Frame: 7 days
Daily time spent sitting/lying and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.
7 days
Readmission
Time Frame: 3 months after discharge
Number of readmission with three months after discharge
3 months after discharge
Falls
Time Frame: 1 month after discharge
Number of falls within the first month after discharge.
1 month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

May 15, 2024

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • F-24023831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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