Clinical trial NCT06410014: Assessment of Overall Functioning in Patients With Complex Health Issues
Official title: Assessment of Overall Functioning in Patients With Complex Health Issues
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Activities of Daily Living
Surveys and Questionnaires
ADL Motor Skills
Disability Evaluation
Health Status
Muscle Strength
Physical Examination
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Motor and Process Skills (AMPS)
timeFrame: Within 21 days from baseline
Secondary outcomes:
measure: 30 seconds chair stand test
timeFrame: Baseline
measure: Hand Grip strength
timeFrame: Baseline
measure: Cumulated Ambulation Score (CAS)
timeFrame: Baseline
measure: ADL-I
timeFrame: Within 21 days from baseline
measure: ADL-Q
timeFrame: Within 21 days from baseline
measure: Work Rehabilitation Questionnaire (WORQ)
timeFrame: The questionnaire is responded one time during a periode ranging from 7 days prior to baseline until 21 days after baseline
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Afdeling for Socialmedicin
Study officials:
affiliation: Department of Social Medicine
name: Jan Renneberg, DMSc
role: STUDY_CHAIR
affiliation: Department of Social Medicine
name: Anna Karnøe Knudsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: