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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
Scientific title
The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships
Secondary ID [1] 0 0
P-2020-706
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Diabetes 0 0
Mental Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relational empowerment
Timepoint [1] 0 0
Baseline

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to read and understand Danish (for danish participants) or English (for UK and australian participants)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/08/2023
Actual
Sample size
Target
Accrual to date
Final
526
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Deakin University, Online - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Rigshospitalet, Denmark
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
King's College London
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Deakin University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vibeke Zoffmann, Professor
Address 0 0
Rigshospitalet, Denmark
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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