## Protocol Section
### Identification Module
**NCT ID:** NCT06421246

**Brief Title:** Activity in Geriatric Patients and Validation of the Danish Version of the Acute Care Mobility Assessment

**Official Title:** Activity in Geriatric Patients and Validation of the Danish Version of the Acute Care Mobility Assessment

#### Organization Study ID Info
**ID:** F-24023831
#### Organization
**Class:** OTHER
**Full Name:** Copenhagen University Hospital, Hvidovre
### Status Module
#### Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Copenhagen University Hospital, Hvidovre

#### Responsible Party

**Investigator Affiliation:** Copenhagen University Hospital, Hvidovre

**Investigator Full Name:** Mette Merete Pedersen

**Investigator Title:** Senior Researcher

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Acute Disease

- Old Age

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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

**Name:** Activity monitoring and validity of the Danish Version of the Acute Care Mobility Assessement

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Number of daily steps taken assessed by a SENS motion accelerometer from inclusion and throughout hospitalization

**Measure:** Daily steps

**Time Frame:** 7 days

#### Secondary Outcomes

**Description:** 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.

**Measure:** Self-reported mobility

**Time Frame:** Days 2, 4 and 6 after inclusion

**Description:** 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.

**Measure:** Life Space mobility

**Time Frame:** At inclusion

**Description:** 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.

**Measure:** Self-reported pre-admission mobility

**Time Frame:** At inclusion

**Description:** 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)

**Measure:** Frailty

**Time Frame:** At inclusion

**Description:** 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).

**Measure:** Cognitive status

**Time Frame:** At inclusion

**Description:** 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.

**Measure:** Activities of daily living

**Time Frame:** At inclusion

**Description:** 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.

**Measure:** Basic mobility

**Time Frame:** Days 2, 4 and 6 after inclusion

**Description:** 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

**Measure:** Highest level of mobility

**Time Frame:** At inclusion

**Description:** 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.

**Measure:** Gait speed

**Time Frame:** At inclusion

**Description:** Daily time spent walking assessed by a SENS motion accelerometer from inclusion and throughout hospitalization

**Measure:** Daily walking

**Time Frame:** 7 days

**Description:** Daily time spent standing assessed by a SENS motion accelerometer from inclusion and throughout hospitalization

**Measure:** Daily standing

**Time Frame:** 7 days

**Description:** Daily time spent sitting/lying assessed by a SENS motion accelerometer from inclusion and throughout hospitalization

**Measure:** Daily lying/sitting

**Time Frame:** 7 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 65 years
* no delirium
* ability to ambulate

Exclusion Criteria:

* in isolation
* teminally ill

**Minimum Age:** 65 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mette.merete.pedersen@regionh.dk

**Name:** Mette M Pedersen, PhD

**Phone:** +4538623350

**Role:** CONTACT

**Contact 2:**

**Email:** lea.kromann.johansen.01@regionh.dk

**Name:** Lea K Johansen, MHSc

**Phone:** +4538621590

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hvidovre

**Contacts:**

***Contact 1:***

- **Email:** mette.merete.pedersen@regionh.dk

- **Name:** Mette M Pedersen, PhD

- **Phone:** +4538623350

- **Role:** CONTACT

***Contact 2:***

- **Email:** lea.kromann.johansen.01@regionh.dk

- **Name:** Lea K Johansen, MHSc

- **Phone:** +4538621590

- **Role:** CONTACT

***Contact 3:***

- **Name:** Mette M Pedersen, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Lea K Johansen, MHSc

- **Role:** SUB_INVESTIGATOR

**Country:** Denmark

**Facility:** Copenhagen University Hospital, Hvidovre

**Status:** RECRUITING

**Zip:** 2650

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3564

- Name: Acute Disease

- Relevance: HIGH

- As Found: Acute Disease

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000208

- Term: Acute Disease

### Misc Info Module

- Version Holder: 2024-05-31
