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Clinical Trials/NCT06410014
NCT06410014RecruitingNot Applicable

Assessment of Overall Functioning in Patients With Complex Health Issues

University Hospital Bispebjerg and Frederiksberg1 site in 1 country100 target enrollmentStarted: October 10, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Assessment of Motor and Process Skills (AMPS)

Study Overview

Brief Summary

The overall aim of the study is to assess whether each outcome measures the same aspect of overall functioning or contributes with different aspects. More specifically, the aim of this study is to investigate the correlation between each single instrument.

During study period all patients presenting at our clinic will be offered to participate in the study. Patients will be included in the study when referred to the department of Social Medicine and providing written informed consent to participate in the study. Inclusion will continue until 100 patients have completed an AMPS test. All participants will, apart from standard procedure, be asked to complete:

  • An AMPS-test
  • ADL-Q (Questionnaire concerning Activities of Daily Living)
  • ADL-I (Interview based questionnaire concerning Activites of Daily Living)

As standard procedure all participants will also perform/complete:

  • 30 seconds chair stand test (30sCST)
  • Hand grip strength (HGS)
  • Evaluation of ambulation (Cumulated Ambulation Score /CAS)
  • WORQ (Work Rehabilitation Questionnaire)

To obtain the aim of the study correlation-analysis will be performed to investigate the relationship between each included instruments.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients referred by a municipality to the Department of Social Medicine at Bispebjerg and Frederiksberg Hospital for a clinical assessment (Klinisk Funktion) who provide written consent to participate.

Exclusion Criteria

  • Insufficient ability to communicate either in written or oral Danish

Outcomes

Primary Outcomes

Assessment of Motor and Process Skills (AMPS)

Time Frame: Within 21 days from baseline

Based on observation of 2 ADL tasks the quality of 16 motor and 20 process skills are scored on a four-point ordinal scale. Using Rasch analysis the raw ordinal scores are converted into two overall ADL ability measures, representing ADL motor and ADL process ability expressed in logits.

Secondary Outcomes

  • Cumulated Ambulation Score (CAS)(Baseline)
  • 30 seconds chair stand test(Baseline)
  • Work Rehabilitation Questionnaire (WORQ)(The questionnaire is responded one time during a periode ranging from 7 days prior to baseline until 21 days after baseline)
  • ADL-I(Within 21 days from baseline)
  • Hand Grip strength(Baseline)
  • ADL-Q(Within 21 days from baseline)

Investigators

Sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anna Karnøe Knudsen

Prinicipal Investigator

University Hospital Bispebjerg and Frederiksberg

Study Sites (1)

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