Activities of Daily LivingCPH-FuncNCT06410014
Assessment of Overall Functioning in Patients With Complex Health Issues
An observational study of Activities of Daily Living and Surveys and Questionnaires, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Activities of Daily Living, Surveys and Questionnaires, ADL Motor Skills
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2023to 19 Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Insufficient ability to communicate either in written or oral Danish
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
- Being tested
- No intervention is performed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is performedOther
The study is observational
| Study group | Role | What they receive |
|---|---|---|
| Participating patients | All patient who have consented to participate in the study Receives: Other: No intervention is performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 21 days from baseline
Secondary outcomes (6)
30 seconds chair stand test
Total number of stands performed in 30 seconds
Measured: Baseline
Hand Grip strength
Measured in kilograms
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: The questionnaire is responded one time during a periode ranging from 7 days prior to baseline until 21 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start10 Oct 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activities of Daily LivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Karnøe Knudsen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Jan Renneberg, DMSc, Study chair, Department of Social MedicineAnna Karnøe Knudsen, M.D., Principal investigator, Department of Social Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410014
- Sponsor's protocol ID
- H23030964
- Acronym
- CPH-Func
- Status last verified
- May 2025
- First submitted
- 11 Mar 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No