An Adjusted Preventive Program Against Lifestyle Related Diseases

NCT03913585 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4800

Last updated 2019-04-16

No results posted yet for this study

Summary

A large proportion of the Danish population leads an unhealthy lifestyle. The associated surge in lifestyle-related disease (LRD) represents a significant health and economic burden for the individual as well as society. However, the reactive nature of the Danish national health-care system, complicates a comprehensive and concerted preventive response to this issue. The TOF project aims to remedy this situation by 1) Using digital support systems to systematically identify citizens at risk of LRD and 2) Target the preventive services at citizens with the highest need. Specifically, the ultimate goal of TOF is to integrate the clinical and municipal preventive primary health-care system into a targeted preventive service that facilitates lifestyle change in the at-risk population, and thus reduces LRD at a population level. To this end, we have developed a complex intervention in close collaboration with central stakeholders (health professionals, citizens). The initial feasibility of the intervention has been tested in a pilot study comprising two municipalities, 47 GPs, and 8814 citizens. The intervention has subsequently been adjusted in collaboration with the end users, focusing both on recruitment activities and implementation activities in general practice. The upcoming step involves testing of the adjusted intervention (Pilot2), before large-scale implementation and efficacy evaluation.

The feasibility, acceptability, and short-term effect of the adjusted intervention will be tested in two municipalities using quantitative as well as qualitative research methods. The evaluation will focus on the reach of the intervention, the implementation and acceptability of the intervention in general practice and municipality, the use and assessment of the digital support system and the possible short-term effects on patient lifestyle and risk of disease. We expect 15 general practitioners and 4800 patients to participate.

The intervention comprises four main components:

1. Participants will be screened for LRD-risk factors by survey
2. Survey information is linked with participants' medical history in order to stratify participants into designated risk groups
3. Depending on risk level, participants will be offered targeted interventions at the GP or municipality.
4. Throughout the intervention, a digital support system providing personalized feedback and advice (health profile) to participants will be accessible to both participants and health professionals.

Conditions

  • Lifestyle-Related Disorder

Interventions

BEHAVIORAL

Lifestyle intervention

Upon inclusion and consent all patients receive a questionnaire to estimate risk of disease and risk behavior. Information about lifestyle is systematically registered and collated with existing Electronic Patient Record (EPR) data and the patients risk of developing a lifestyle-related disease is estimated based on validated algorithms for risk of type-2 diabetes, cardiovascular disease and COPD (Stratification). All patients receive digital feedback including a personal health profile and targeted advice. Patients at high risk of lifestyle-related disease(s) are offered targeted prevention activities at the GP including a health examination and if needed a health dialog. Patients with health risk behavior are offered behavior counselling in the municipality and community health services, if necessary. Patients diagnosed with a lifestyle related disease and patients with a healthy lifestyle are not offered any further services.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER
  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Trine Thilsing, DVM, PhD, Associate professor · Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark, DK-5000 Odense C, Denmark

  • Jens Søndergaard, MD, PhD, professor, head of research unit · Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark, DK-5000 Odense C, Denmark

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
29 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2020-05-31
Completion
2020-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03913585 on ClinicalTrials.gov