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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05277805




Registration number
NCT05277805
Ethics application status
Date submitted
3/03/2022
Date registered
14/03/2022
Date last updated
30/03/2023

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
Cross-sectional
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
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT05277805
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