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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05277805
Registration number
NCT05277805
Ethics application status
Date submitted
3/03/2022
Date registered
14/03/2022
Titles & IDs
Public title
The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships
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Scientific title
The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships
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Secondary ID [1]
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P-2020-706
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
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Diabetes
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Mental Disorder
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - EMPOWER-UP questionnaire
EMPOWER-UP participants - People with cancer, diabetes, or mental disorders answering the EMPOWER-UP questionnaire
Other interventions: EMPOWER-UP questionnaire
Participants are asked to respond to the EMPOWER-UP questionnaire to test the psychometric properties of the questionnaire.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Relational empowerment
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Assessment method [1]
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EMPOWER-UP questionnaire
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Timepoint [1]
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Baseline
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Eligibility
Key inclusion criteria
* Ever diagnosed with cancer, diabetes, or a mental disorder AND have had an interaction with a healthcare provider concerning their cancer/diabetes/mental disorder diagnosis within the past six months (relating to e.g. treatment or follow-up consultations)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Unable to read and understand Danish (for danish participants) or English (for UK and australian participants)
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/08/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
526
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Deakin University, Online - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Copenhagen
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Country [2]
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United Kingdom
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State/province [2]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rigshospitalet, Denmark
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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King's College London
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Deakin University
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Empowerment is widely acknowledged as an important approach in long-term care. The concept relates to the individual's ability to manage their own life and make rational decisions. Despite good intentions of working empowerment-based, research has shown that it can be difficult to realize and achieve in everyday practice within the healthcare system. To this date, no measurement instrument (questionnaire) exists that evaluate people's perceptions of whether their relationship with a healthcare provider promotes their empowerment process. The EMPOWER-UP questionnaire was therefore developed to provide such a measure. The EMPOWER-UP study aims to finalize the development process of the questionnaire and to test whether it is a valid and reliable measure. People at the age of 18 years or above can participate if they have ever been diagnosed with a type of cancer, diabetes, or a mental illness and because of that diagnosis have been in contact with the healthcare system within the past six months. The study is conducted online and requires participants to fill out an online questionnaire on a single occasion. Participation is expected to take no more than 10-15 minutes. By participating, people may experience an increased awareness as to the nature of their interactions with healthcare providers. For some, this awareness may be beneficial and may alone enable them to ask for better care, while others may experience it as a burden if they are not able to seek better care. By participating, people are helping to ensure that EMPOWER-UP will be a good questionnaire that may help raise awareness of the quality of relationships within the healthcare system and in term lead to better care. The study is led by a team of researchers at the Danish University Hospital Rigshospitalet and the University of Copenhagen, Denmark. The UK lead of the study is located at King's College London, UK. The Australian lead of the study is located at Deakin University, Melbourne, Australia. This study is financially supported by the Novo Nordisk Foundation's Steno Collaborative Grant and by the Trygfonden foundation (Denmark)
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Trial website
https://clinicaltrials.gov/study/NCT05277805
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Vibeke Zoffmann, Professor
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Address
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Rigshospitalet, Denmark
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05277805