(Cost)effectiveness of the Intervention 'Gezond En Goed Met Elkaar'

Not Applicable

Recruiting

• Conditions: The Study is Focused on People with Limited Health Literacy; We Are Not Studying a Disease or Condition

• Registration Number: NCT06644547
• Lead Sponsor: VU University of Amsterdam

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-26
• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-05-01
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 18 years or older

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Positive Health	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	From baseline measurement to 9 months later	SF-12 Vitality (VT) question 6b

Secondary Outcome Measures

Name	Time	Method
Health Literacy	From baseline measurement to 9 months later	HLS-EU-Q16 adapted to B1 language level For the psychometric analyses of HLS-EU-Q16, each of the 16 questions were coded according to the following: 'very difficult'=1 point, 'fairly difficult'=2 points, 'fairly easy'=3 points or 'very easy'=4 points, giving a total of 16-64 scores. The HLS-EU-Q16 manual recommends dichotomizing the answers from HLS-EU-Q16 ('very difficult'/'fairly difficult'=0, 'fairly easy'/'very easy'=1; total 0-16 scores); 1 \& 2 -\> 0 3 \& 4 -\> 1; dividing the total scores into three categories of HL: 0-8 = inadequate 9-12 = problematic 13-16 = adequate
Basic Psychological Needs	From baseline measurement to 9 months later	BPNSFS-ID: Basic Psychological Needs Satisfaction and Frustration Scale
Well-Being	From baseline measurement to 9 months later	ASCOT: The Adult Social Care Outcomes Toolkit - dutch translation
Quality of Life (QALYs)	From baseline measurement to 9 months later	EQ-5D-5L: 5-level EQ-5D version (EuroQol Group, 2009)
Health Care and Productivity Costs	From baseline measurement to 9 months later	Cost questionnaire developed by Health Sciences Department (Economic Evaluation) of VU University of Amsterdam

Trial Locations

Locations (1)

Vrije Universiteit Amsterdam; 🇳🇱 Amsterdam, Netherlands