Assessment of Overall Functioning in Patients With Complex Health Issues (CPH-Func)

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 Overview

• Status: Recruiting
• Conditions: Activities of Daily Living; Muscle Strength; Disability Evaluation; Surveys and Questionnaires; Health Status; Physical Examination; ADL Motor Skills
• Intervention / Treatment: Other: No intervention is performed

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Anna Karnøe Knudsen, M.D.; Phone Number: +4521744720; Email: anna.karnoee.knudsen@regionh.dk
• Study Contact Backup: Name: Poul Frost, M.D. Ph.D.; Phone Number: +45 38 64 98 00; Email: poul.frost@regionh.dk

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • Recruiting
    • Afdeling for Socialmedicin
    • Contact: Anna Karnøe Knudsen, M.D.; Phone Number: +4521744720; Email: anna.karnoee.knudsen@regionh.dk
    • Contact: Poul Frost, M.D. Ph.D.; Phone Number: +45 38 64 98 00; Email: poul.frost@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participating patients; All patient who have consented to participate in the study	Other: No intervention is performed; The study is observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 seconds chair stand test	Total number of stands performed in 30 seconds	Baseline
Hand Grip strength	Measured in kilograms	Baseline
Cumulated Ambulation Score (CAS)	Scoring of three mobility activities on a three point ordinal scale (zero to 2). The scores are summed resulting in a total score ranging from 0 to 6.	Baseline
ADL-I	Raw data collected in the interview is scored on a four-point ordinal scale and subsequently converted into a linear measure of self-reported ADL ability expressed in logits (log-odds probability units).	Within 21 days from baseline
ADL-Q	Raw data collected in the questionnaire is scored on a four-point ordinal scale and subsequently converted into a linear measure of self-reported ADL ability expressed in logits (log-odds probability units).	Within 21 days from baseline
Work Rehabilitation Questionnaire (WORQ)	The questionnaire consists of 17 items on sociodemographic topics and 40 items related to overall functioning. The 40 items are each scored on a response scale ranging from 0 to 10. The results are summed in four linear subscales addressing emotion, cognition, dexterity and mobility. A total sum score is performed.	The questionnaire is responded one time during a periode ranging from 7 days prior to baseline until 21 days after baseline

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Investigators: Study Chair: Jan Renneberg, DMSc, Department of Social Medicine; Principal Investigator: Anna Karnøe Knudsen, M.D., Department of Social Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H23030964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No