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Clinical Trials/NCT06644547
NCT06644547
Completed
Not Applicable

(Cost)Effectiveness of the Intervention 'Gezond en Goed Met Elkaar'

VU University of Amsterdam2 sites in 1 country100 target enrollmentJune 26, 2024

Overview

Phase
Not Applicable
Intervention
Gezond en goed met elkaar
Conditions
The Study is Focused on People with Limited Health Literacy
Sponsor
VU University of Amsterdam
Enrollment
100
Locations
2
Primary Endpoint
Positive Health
Status
Completed
Last Updated
3 days ago

Overview

Brief Summary

The goal of this intervention study is to learn if the intervention can increase positive health and health literacy in people with limited health literacy. The main questions it aims to answer are:

  • Does participating in the intervention 'Gezond en goed met elkaar' increase participant's positive health?
  • Does participating in the intervention 'Gezond en goed met elkaar' improve health literacy?

Researchers will compare people who participate in the intervention with people who haven't participated in the intervention yet.

Participants will:

  • participate in the intervention (3 months)
  • fill out questionnaires every 3 months
Registry
clinicaltrials.gov
Start Date
June 26, 2024
End Date
August 18, 2025
Last Updated
3 days ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
VU University of Amsterdam
Responsible Party
Principal Investigator
Principal Investigator

Iris Koelmans

Principal Investigator

VU University of Amsterdam

Eligibility Criteria

Inclusion Criteria

  • 18 years or older

Exclusion Criteria

  • analfabetism
  • insufficient language level of Dutch to be able to participate in the intervention

Arms & Interventions

Intervention 'Gezond en goed met elkaar'

see description of the intervention 'Gezond en goed met elkaar'

Intervention: Gezond en goed met elkaar

Control group

Participants do not receive the intervention yet. They have to wait 3 months before they start with the intervention. They will fill out questionnaires at baseline, 3, 6 and 9 months.

Control group 2

Participants do not receive the intervention yet. They have to wait 6 months before they start with the intervention. They will fill out questionnaires at baseline, 3, 6 and 9 months.

Outcomes

Primary Outcomes

Positive Health

Time Frame: From baseline measurement to 9 months later

Positive Health questionnaire developed by Institute of Positive Health (iPH) 17 items, answered on a 10-point Likert scale

Vitality

Time Frame: From baseline measurement to 9 months later

SF-12 Vitality (VT) question 6b

Secondary Outcomes

  • Health Literacy(From baseline measurement to 9 months later)
  • Basic Psychological Needs(From baseline measurement to 9 months later)
  • Well-Being(From baseline measurement to 9 months later)
  • Quality of Life (QALYs)(From baseline measurement to 9 months later)
  • Health Care and Productivity Costs(From baseline measurement to 9 months later)

Study Sites (2)

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