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NCT Number: NCT06410014

Assessment of Overall Functioning in Patients With Complex Health Issues

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention is performed

Other

The study is observational

Primary outcomes

  1. 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

  1. 30 seconds chair stand test

    Time frame: Baseline

    Total number of stands performed in 30 seconds

  2. Hand Grip strength

    Time frame: Baseline

    Measured in kilograms

  3. Cumulated Ambulation Score (CAS)

    Time frame: Baseline

    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.

  4. ADL-I

    Time frame: Within 21 days from baseline

    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).

  5. ADL-Q

    Time frame: Within 21 days from baseline

    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).

  6. Work Rehabilitation Questionnaire (WORQ)

    Time frame: The questionnaire is responded one time during a periode ranging from 7 days prior to baseline until 21 days after baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Karnøe Knudsen, M.D.

CONTACT

[email protected]

+4521744720

Poul Frost, M.D. Ph.D.

CONTACT

[email protected]

+45 38 64 98 00

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Acronym: CPH-Func

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 10, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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