AzTrials
AzTrials

Acute DiseaseNCT06421246

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

An observational study of Acute Disease and Old Age, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Acute Disease, Old Age
What is being tested?
Staff-facing screen
How many people
100 participants
Where
1 siteDenmark
Study dates
15 May 2024to 30 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • 65 years
  • no delirium
  • ability to ambulate

Who cannot join

  • in isolation
  • teminally ill
  • Expected to be discharged within 24-hours from inclusion

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen University Hospital, Hvidovre

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: 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.

Read the 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).

Being tested
Staff-facing screen
Medical subject headings
Acute Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Staff-facing screenBehavioural

    Activity will be monitored before and after the introduction of a staff-facing screen

Study groups in NCT06421246
Study groupRoleWhat they receive
Activity monitoring and validity of the Danish Version of the Acute Care Mobility Assessement24- 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.
Receives: Behavioral: Staff-facing screen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily steps

    Number of daily steps taken and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.

    Measured: 7 days

Secondary outcomes (15)

  1. Self-reported mobility

    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.

    Measured: Days 2, 4 and 6 after inclusion

  2. Life Space mobility

    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.

    Measured: At inclusion, 4 weeks post discharge

  3. Self-reported pre-admission (2 weeks prior to admission) and post discharge mobility

    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.

    Measured: At inclusion and 1 week after discharge

  4. Frailty

    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)

    Measured: At inclusion

  5. Cognitive status

    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).

    Measured: At inclusion

  6. Activities of daily living

    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.

    Measured: At inclusion and 1 week after discharge

  7. Basic mobility

    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.

    Measured: Days 2, 4 and 6 after inclusion

  8. Highest level of mobility

    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

    Measured: At inclusion

  9. Gait speed

    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.

    Measured: At inclusion

  10. Uptime

    Daily time spent in uptime and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.

    Measured: 7 days

  11. Daily walking

    Daily time spent walking and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.

    Measured: 7 days

  12. Daily standing

    Daily time spent walking assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.

    Measured: 7 days

  13. Daily lying/sitting

    Daily time spent sitting/lying and the distribution over the entire hospitalization, assessed by a SENS motion accelerometer from inclusion and throughout hospitalization.

    Measured: 7 days

  14. Readmission

    Number of readmission with three months after discharge

    Measured: 3 months after discharge

  15. Falls

    Number of falls within the first month after discharge.

    Measured: 1 month after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2024
  2. Study start15 May 2024
  3. Primary completion14 Mar 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06421246
Sponsor's protocol ID
F-24023831
Status last verified
Oct 2024
First submitted
10 May 2024
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Johansen LK, Larsen TS, Kirk JW, Pedersen BS, Nielsen BR, Kallemose T, Bandholm T, Pedersen MM. Exploring in-hospital mobility practices for geriatric patients: insights from a mixed-method study. BMC Geriatr. 2025 May 13;25(1):330. doi: 10.1186/s12877-025-05976-9.

    PubMed 40361036

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Disease and Old Age, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily steps (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06421246, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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