Lifestyle-Related Disorder Clinical Trial
— TOFpilot2Official title:
Early Detection and Prevention of Lifestyle Related Diseases - Pilot2
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.
Status | Recruiting |
Enrollment | 4800 |
Est. completion date | August 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 29 Years to 59 Years |
Eligibility |
Inclusion Criteria: - GP affiliation: Patients affiliated to one of the participating GPs - Year of birth: 1959-1988 - Place of recidence: Municipalities of Haderslev or Middelfart Exclusion Criteria: - Patients invited to participate in TOFpilot1 - No access to digital mail (e-Boks) |
Country | Name | City | State |
---|---|---|---|
Denmark | National Institute of Public Health, University of Southern Denmark | Copenhagen | |
Denmark | Department of Sports Science and Clinical Biomechanics, Musculoskeletal Function and Physiotherapy, University of Southern Denmark | Odense | |
Denmark | Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark | Odense | |
Denmark | Department of People and Technology, Roskilde University | Roskilde |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | University of Oslo |
Denmark,
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. — View Citation
Cardiology. ESo. Heartscore BMI score [Internet]. Available from: https://escol.escardio.org/heartscore/calc.aspx?model=europelow
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. Epub 2004 Sep 8. — View Citation
Larsen LB, Sonderlund AL, Sondergaard J, Thomsen JL, Halling A, Hvidt NC, Hvidt EA, Mønsted 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. — View Citation
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. — View Citation
Socialstyrelsen. S. Sjukdomsförebyggande metoder. Vetenskabeligt underlag för nationella riktlinjer. 2011.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Change in patient health risk behaviour (lifestyle) from study commencement to 12 months follow up | Lifestyle is defined by smoking habits, alcohol intake, excercise habits and dietary habits, and health risk behaviour is defines by smoking tobacco on a daily basis, consuming more than 14/21 (male/female) standard units of alcohol per week, sustaining an unhealthy diet (diet score =4 on a 12-point score drawn from the Swedish National Guidelines on Disease Prevention), maintaining a BMI = 35, and/or engaging in a generally sedentary lifestyle. | From receipt of personal health profile (April 2019) to one year follow up | |
Secondary | Qualitative evaluation of the digital support system with focus on experienced usefulness | Participant observations about using the digital support system in GP clinics (1-2 days, 2-4 GP clinics), municipal health centers (1-2 days, 2 municipal health centers) and if possible at citizens homes. Interviews of general practice staff, municipal health professionals, and patients conducted during and after the observations. |
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. | |
Secondary | Qualitative process evaluation focusing on the intervention in general practice | Ethnographic observational studies of 10 patients, stratified to receive a health check and dialogue with their GP/practice staff. The interaction between these patients and the relevant health professional will be observed, and both parties will further be asked to participate in semi-structured individual interviews. | 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. | |
Secondary | Qualitative process evaluation focusing on the intervention in the municipality | Ten participants who receive health advice/assistance from their municipality will be asked to participate in semi-structured individual interviews. One or two focus groups with municipal health-care staff and leaders will be conducted in each participating 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. | |
Secondary | Patients' perceptions of relational empathy following the health dialogue at the GP and municipality | Following each behavior counseling session in general practice and municipality the patients perception of the health professionals empathy is measured by The Consultation And Relational Empathy (CARE) measure (score range: 10-50) | Immediately following each health dialogue | |
Secondary | Patient reported self-efficacy before study commencement and at one year follow up | Participants self-efficacy will be assessed before study commencement and at one year follow up using the The General Self-Efficacy Scale (total score range: 10-40; The higher the score, the higher the level of self-efficacy) | At consent and 1 year follow up | |
Secondary | Patient reported mental well-being before study commencement, immediately after the study period and at one year follow up | Participants mental well-being will be assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (total score range: 7-35; The higher the score, the higher the level of mental well-being) | At consent, immediately after the study period and at 1 year follow up | |
Secondary | Participants social network before study commencement and at one year follow up | The extent and quality of the participants social network will be assessed using Lubbens Social Network Scale 6 (LSNS-6) (total scale range: 0-60; the higher the score, the stronger the social network) | At consent and 1 year follow up | |
Secondary | Perceived social network norms before study commencement and at one year follow up | The perception of participants with regard to the social networks norms on lifestyle will be assesed using a validated two-item measure from the Theory of Planned Behavior | At consent and 1 year follow up | |
Secondary | Osteoarthritis risk factors at study commencement and one year follow up | Prevalence of osteoarthritis (OA) risk factors will be assessed by questions on the presence of persistent knee and/or hip pain, previous knee/hip injury, previous knee/hip surgery, leisure time physical activity, and family history of OA | From receipt of personal health profile (April 2019) to one year follow up | |
Secondary | Uptake of targeted intervention against osteoarthritis (GLA:D) | The number of participants taking up a targeted intervention against osteoarthritis (GLA:D) will be assessed from the GLA:D-register | From receipt of personal health profile (April 2019) to one year follow up | |
Secondary | Change in proportion of patients at increased risk of diabetes from study commencement to 12 months follow up | Risk of diabetes is identified using the validated risk score: the Danish Diabetes Risk model. The Danish Diabetes Risk score is based on an algorithm that incorporates age, sex, BMI, known hypertension, leisure activity level, and family history of diabetes. | From receipt of personal health profile (April 2019) to one year follow up | |
Secondary | Change in proportion of patients at increased risk of COPD from study commencement to 12 months follow up | Risk of COPD is identified using the validated risk score: the Chronic Obstructive Pulmonary Disease Population Screener (COPD-PS). The COPD-PS uses an algorithm accounting for age, lifetime use of cigarettes, and smoking-related symptoms to identify at-risk patients who may benefit from a spirometry to test for COPD. | From receipt of personal health profile (April 2019) to one year follow up | |
Secondary | Change in proportion of patients at increased risk of CVD from study commencement to 12 months follow up | Risk of CVD is identified using a modified Heartscore BMI score. The modified Heartscore BMI score accounts for age, sex, body mass index (BMI), and smoking status. | From receipt of personal health profile (April 2019) to one year follow up | |
Secondary | Patients perception of the shared decision making proces during health consultations | Shared decision making is measured by the The 9-item Shared Decision Making Questionnaire (SDM-Q-9) | Immediately following each health dialogue | |
Secondary | Health professionals perception of the shared decision making proces during health consultations | Shared decision making is measured by the The 9-item Shared Decision Making Questionnaire (SDM-Q-doc) | Immediately following each health dialogue | |
Secondary | Patient reported meaning-making | Questionnaire items sampled from the validated questionnaire SoMe (Sources of Meaning) and European Value Study (EVS). | At consent and at one year follow up | |
Secondary | Patient reported spiritual wellbeing | Questionnaire items from the validated questionnaire SoMe (Sources of Meaning) and European Value Study (EVS). | At consent and at one year follow up | |
Secondary | Patient reported religious belief and practices | Questionnaire items sampled from the validated questionnaire SoMe (Sources of Meaning) and European Value Study (EVS). | At consent and at one year follow up |