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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06421246
Other study ID # F-24023831
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date July 15, 2024

Study information

Verified date May 2024
Source Copenhagen University Hospital, Hvidovre
Contact Mette M Pedersen, PhD
Phone +4538623350
Email mette.merete.pedersen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Description:

During two month, 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. Demografic 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 65 years - no delirium - ability to ambulate Exclusion Criteria: - in isolation - teminally ill

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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, and the Acute Care mobility assessment will be validated by cognitive debriefing interviews in 5-10 patients

Locations

Country Name City State
Denmark Copenhagen University Hospital, Hvidovre Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily steps Number of daily steps taken assessed by a SENS motion accelerometer from inclusion and throughout hospitalization 7 days
Secondary 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. Days 2, 4 and 6 after inclusion
Secondary 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. At inclusion
Secondary Self-reported pre-admission 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. At inclusion
Secondary 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) At inclusion
Secondary 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). At inclusion
Secondary 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. At inclusion
Secondary 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. Days 2, 4 and 6 after inclusion
Secondary 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 At inclusion
Secondary 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. At inclusion
Secondary Daily walking Daily time spent walking assessed by a SENS motion accelerometer from inclusion and throughout hospitalization 7 days
Secondary Daily standing Daily time spent standing assessed by a SENS motion accelerometer from inclusion and throughout hospitalization 7 days
Secondary Daily lying/sitting Daily time spent sitting/lying assessed by a SENS motion accelerometer from inclusion and throughout hospitalization 7 days
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