Assessment of Overall Functioning in Patients With Complex Health Issues

NCT06410014 | Recruiting

• 1 other identifier: H23030964
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Activities of Daily Living; Surveys and Questionnaires; ADL Motor Skills; Disability Evaluation; Health Status; Muscle Strength; Physical Examination

Outcome Measures

Primary Outcomes (1)

• Assessment of Motor and Process Skills (AMPS)

  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.

  Within 21 days from baseline

Secondary Outcomes (6)

• 30 seconds chair stand test

  Baseline

• Hand Grip strength

  Baseline

• Cumulated Ambulation Score (CAS)

  Baseline

• ADL-I

  Within 21 days from baseline

• ADL-Q

  Within 21 days from baseline

Study Arms (1)

Participating patients

All patient who have consented to participate in the study

Other: No intervention is performed

Interventions

No intervention is performed OTHER

The study is observational

Participating patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The department of social medicine receives patients referred by the municipality for a general clinical examination and an assessment of overall functioning (Klinisk Funktion). The criteria of referral are a need of a medical assessment of complex health issues and the impact on functioning and/or symptoms with no equivalent objective findings. Generally, the patients referred are characterized by complex health issues and several years of unemployment. The conclusion, which consists of a medical review and an assessment of overall functioning, is sent to the municipality and used e.g., in their assessment of workability and social insurance.

You may qualify if:

• 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.

You may not qualify if:

• Insufficient ability to communicate either in written or oral Danish

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Afdeling for Socialmedicin

Frederiksberg, 2000, Denmark

RECRUITING

Study Officials

• Jan Renneberg, DMSc

  Department of Social Medicine

  STUDY CHAIR

• Anna Karnøe Knudsen, M.D.

  Department of Social Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Karnøe Knudsen, M.D.

CONTACT

+4521744720; anna.karnoee.knudsen@regionh.dk

Poul Frost, M.D. Ph.D.

CONTACT

+45 38 64 98 00; poul.frost@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: May 10, 2024
• Study Start: October 10, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)