NCT05277805

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 Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
526

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

March 3, 2022

Last Update Submit

March 28, 2023

Conditions

CancerDiabetesMental Disorder

Outcome Measures

Primary Outcomes (1)

  • Relational empowerment

    EMPOWER-UP questionnaire

    Baseline

Study Arms (1)

EMPOWER-UP participants

People with cancer, diabetes, or mental disorders answering the EMPOWER-UP questionnaire

Other: EMPOWER-UP questionnaire

Interventions

EMPOWER-UP questionnaireOTHER

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

EMPOWER-UP participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Deakin University, Online

Melbourne, Australia

Location

Rigshospitalet, online

Copenhagen, Denmark

Location

King's College London, online

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

NeoplasmsDiabetes MellitusMental Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vibeke Zoffmann, Professor

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d. student, MSc

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

January 1, 2020

Primary Completion

October 11, 2022

Study Completion

August 23, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

DK(1)GB(1)AU(1)