NCT03913585

Brief 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. 1.Participants will be screened for LRD-risk factors by survey
  2. 2.Survey information is linked with participants' medical history in order to stratify participants into designated risk groups
  3. 3.Depending on risk level, participants will be offered targeted interventions at the GP or municipality.
  4. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

October 5, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

October 5, 2018

Last Update Submit

April 12, 2019

Conditions

Lifestyle-Related Disorder

Keywords

Tailored lifestyle interventionSelective preventionPrimary careWeb based health risk assessmentPatient-centered health information system

Outcome Measures

Primary Outcomes (3)

  • Participation (Consent)

    Participation (Consent) is defined as the proportion of citizens who following the initial invitation concents to take part in the study.

    From initial invitation (consent) (October 2018) to deadline for consent (6 weeks later)

  • Participation (Personal Health Profile)

    Participation (Personal Health Profile) is defined as the proportion of consenting participants who receives a personale health profile.

    From invitation to receive a personal health profile (April 2019) to deadline for receiving the personal health profile (4 months later)

  • Participation (Targeted intervention in General practice or Municipality)

    Participation (Targeted intervention in General practice or Municipality) is defined as the proportion of participants (Personal Health Profile) who takes up the targeted intervention in general practice or municipality.

    From second invitation (April 2019) to deadline for receiving the targeted interventions (4 months later)

Secondary Outcomes (19)

  • Change in patient health risk behaviour (lifestyle) from study commencement to 12 months follow up

    From receipt of personal health profile (April 2019) to one year follow up

  • Qualitative evaluation of the digital support system with focus on experienced usefulness

    Observations will be conducted during full working days at the municipal health centers and in general practice. Interviews will be of approximately 30 minutes duration.

  • Qualitative process evaluation focusing on the intervention in general practice

    Observations will be conducted during the health checks (10 minutes) and the health dialogues (30 minutes). The subsequent interviews will be of up to 30 minutes duration.

  • Qualitative process evaluation focusing on the intervention in the municipality

    The semistructured individual interviews will be of up to 30 minutes duration. The focus group interviews will be of up to 2 hours duration.

  • Patients' perceptions of relational empathy following the health dialogue at the GP and municipality

    Immediately following each health dialogue

  • +14 more secondary outcomes

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL

The intervention group comprises \~4800 patients born 1959-1988, living in the municipalities of Haderslev or Middelfart, and affiliated to one of the participating GPs. No control group is included.

Behavioral: Lifestyle intervention

Interventions

Lifestyle interventionBEHAVIORAL

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.

Also known as: TOF project
Lifestyle intervention

Eligibility Criteria

Age29 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • GP affiliation: Patients affiliated to one of the participating GPs
  • Year of birth: 1959-1988
  • Place of recidence: Municipalities of Haderslev or Middelfart

You may not qualify if:

  • Patients invited to participate in TOFpilot1
  • No access to digital mail (e-Boks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Institute of Public Health, University of Southern Denmark

Copenhagen, 1353, Denmark

NOT YET RECRUITING

Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark

Odense, 5000, Denmark

RECRUITING

Department of Sports Science and Clinical Biomechanics, Musculoskeletal Function and Physiotherapy, University of Southern Denmark

Odense, 5230, Denmark

NOT YET RECRUITING

Department of People and Technology, Roskilde University

Roskilde, 4000, Denmark

RECRUITING

Related Publications (7)

  • Christensen JO, Sandbaek A, Lauritzen T, Borch-Johnsen K. Population-based stepwise screening for unrecognised Type 2 diabetes is ineffective in general practice despite reliable algorithms. Diabetologia. 2004 Sep;47(9):1566-73. doi: 10.1007/s00125-004-1496-2. Epub 2004 Sep 8.

    PMID: 15365615BACKGROUND

  • Martinez FJ, Raczek AE, Seifer FD, Conoscenti CS, Curtice TG, D'Eletto T, Cote C, Hawkins C, Phillips AL; COPD-PS Clinician Working Group. Development and initial validation of a self-scored COPD Population Screener Questionnaire (COPD-PS). COPD. 2008 Apr;5(2):85-95. doi: 10.1080/15412550801940721.

    PMID: 18415807BACKGROUND

  • Cardiology. ESo. Heartscore BMI score [Internet]. Available from: https://escol.escardio.org/heartscore/calc.aspx?model=europelow

    BACKGROUND

  • Socialstyrelsen. S. Sjukdomsförebyggande metoder. Vetenskabeligt underlag för nationella riktlinjer. 2011.

    BACKGROUND

  • Larsen LB, Sonderlund AL, Sondergaard J, Thomsen JL, Halling A, Hvidt NC, Hvidt EA, Monsted T, Pedersen LB, Roos EM, Pedersen PV, Thilsing T. Targeted prevention in primary care aimed at lifestyle-related diseases: a study protocol for a non-randomised pilot study. BMC Fam Pract. 2018 Jul 21;19(1):124. doi: 10.1186/s12875-018-0820-8.

    PMID: 30031380BACKGROUND

  • Bruun Larsen L, Soendergaard J, Halling A, Thilsing T, Thomsen JL. A novel approach to population-based risk stratification, comprising individualized lifestyle intervention in Danish general practice to prevent chronic diseases: Results from a feasibility study. Health Informatics J. 2017 Dec;23(4):249-259. doi: 10.1177/1460458216645149. Epub 2016 May 31.

    PMID: 27245672BACKGROUND

  • Thilsing T, Larsen LB, Sonderlund AL, Andreassen SS, Christensen JR, Svensson NH, Dahl M, Sondergaard J. Effects of a Co-Design-Based Invitation Strategy on Participation in a Preventive Health Check Program: Randomized Controlled Trial. JMIR Public Health Surveill. 2021 Mar 10;7(3):e25617. doi: 10.2196/25617.

    PMID: 33688836DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Trine Thilsing, DVM, PhD, Associate professor

    Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark, DK-5000 Odense C, Denmark

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Central Study Contacts

Trine Thilsing, DVM, PhD, Associate professor

CONTACT

+45 65507195tthilsing@health.sdu.dk

Jens Søndergaard, MD, PhD, professor, head of research unit

CONTACT

+45 65503691jsoendergaard@health.sdu.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: To test the acceptability, feasibility and short-term effect of a selective preventive program that systematically helps citizens evaluate individual risk of lifestyle related disease and, if needed, offers targeted and coordinated preventive services in the primary health care sector.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

April 12, 2019

Study Start

October 22, 2018

Primary Completion

May 31, 2020

Study Completion

August 31, 2020

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

DK(4)