The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships

Cancer Clinical Trial

Official title:

The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05277805
• Other study ID #: P-2020-706
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: August 23, 2023

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 526
• Est. completion date: August 23, 2023
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Exclusion Criteria:

• Unable to read and understand Danish (for danish participants) or English (for UK and australian participants)

Related Conditions & MeSH terms

• Cancer
• Diabetes
• Mental Disorder
• Mental Disorders

Intervention

Other:
• EMPOWER-UP questionnaire
Participants are asked to respond to the EMPOWER-UP questionnaire to test the psychometric properties of the questionnaire.

Locations

Country	Name	City	State
Australia	Deakin University, Online	Melbourne
Denmark	Rigshospitalet, online	Copenhagen
United Kingdom	King's College London, online	London

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Deakin University, King's College London

Countries where clinical trial is conducted

Australia,  Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relational empowerment	EMPOWER-UP questionnaire	Baseline

External Links

•   Australian data collection
•   Danish data collection URL
•   UK data collection URL