Assessment of Overall Functioning in Patients With Complex Health Issues

Muscle Strength Clinical Trial

— CPH-Func  

Official title:

Assessment of Overall Functioning in Patients With Complex Health Issues

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410014
• Other study ID #: H23030964
• Status: Recruiting
• Start date: October 10, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2024
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Anna Karnøe Knudsen, M.D.
• Phone: +4521744720
• Email: anna.karnoee.knudsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activities of Daily Living
• Disability Evaluation
• Health Status
• Muscle Strength
• Physical Examination
• Surveys and Questionnaires

Intervention

Other:
• No intervention is performed
The study is observational

Locations

Country	Name	City	State
Denmark	Afdeling for Socialmedicin	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 seconds chair stand test	Total number of stands performed in 30 seconds	Baseline
Secondary	Hand Grip strength	Measured in kilograms	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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