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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes; Cancer; Mental Disorder
• Intervention / Treatment: Other: EMPOWER-UP questionnaire

• Study Type: Observational
• Enrollment (Actual): 526

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Deakin University, Online
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet, online
• United Kingdom
  • London, United Kingdom
    • King's College London, online

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EMPOWER-UP participants; People with cancer, diabetes, or mental disorders answering the EMPOWER-UP questionnaire	Other: EMPOWER-UP questionnaire; Participants are asked to respond to the EMPOWER-UP questionnaire to test the psychometric properties of the questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relational empowerment	EMPOWER-UP questionnaire	Baseline

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: King's College London; Deakin University
• Investigators: Study Chair: Vibeke Zoffmann, Professor, Rigshospitalet, Denmark

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): October 11, 2022
• Study Completion (Anticipated): August 23, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: P-2020-706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No