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Completed

NCT Number: NCT06421246

Implementation and Evaluation of Real Time Monitoring of Physical Activity in Geriatric Patients - 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.

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Key information

Conditions

Acute Disease Disease Attributes Old Age Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65 years
  • no delirium
  • ability to ambulate

Exclusion criteria

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

Treatment and study plan

Staff-facing screen

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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).

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. Daily standing

    Time frame: 7 days

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

  13. 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.

  14. Readmission

    Time frame: 3 months after discharge

    Number of readmission with three months after discharge

  15. Falls

    Time frame: 1 month after discharge

    Number of falls within the first month after discharge.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 20, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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