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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Disease
Old Age
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older adults admitted to a geriatric ward at Copenhagen University Hospital, Hvidovre

Brief 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.

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.

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).

Eligibility criteria: Inclusion Criteria:

* 65 years
* no delirium
* ability to ambulate

Exclusion Criteria:

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

Primary outcomes:
measure: Daily steps
timeFrame: 7 days
Secondary outcomes:
measure: Self-reported mobility
timeFrame: Days 2, 4 and 6 after inclusion
measure: Life Space mobility
timeFrame: At inclusion, 4 weeks post discharge
measure: Self-reported pre-admission (2 weeks prior to admission) and post discharge mobility
timeFrame: At inclusion and 1 week after discharge
measure: Frailty
timeFrame: At inclusion
measure: Cognitive status
timeFrame: At inclusion
measure: Activities of daily living
timeFrame: At inclusion and 1 week after discharge
measure: Basic mobility
timeFrame: Days 2, 4 and 6 after inclusion
measure: Highest level of mobility
timeFrame: At inclusion
measure: Gait speed
timeFrame: At inclusion
measure: Uptime
timeFrame: 7 days
measure: Daily walking
timeFrame: 7 days
measure: Daily standing
timeFrame: 7 days
measure: Daily lying/sitting
timeFrame: 7 days
measure: Readmission
timeFrame: 3 months after discharge
measure: Falls
timeFrame: 1 month after discharge
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
Study officials:
References: