Clinical trial NCT05277805: The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships
Official title: The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Diabetes
Mental Disorder
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: King's College London
name: Deakin University
First posted: 2022-03-14
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People are invited to participate through patient organizations, disease-specific patient boards, general care clinics, and outpatient clinics at hospitals in Denmark, the UK, and Australia

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)


Eligibility criteria: 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)

Primary outcomes:
measure: Relational empowerment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Deakin University, Online
city: Copenhagen
country: Denmark
facility: Rigshospitalet, online
city: London
country: United Kingdom
facility: King's College London, online
Study officials:
affiliation: Rigshospitalet, Denmark
name: Vibeke Zoffmann, Professor
role: STUDY_CHAIR
References: