Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education

NCT01979107 | Completed

• 1 other identifier: 61110-2095
• Study Type: interventional
• Target: 1,104
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized controlled study it is investigated if a proactive action by the general practitioner offering individuals without formal education a preventive health check will lead to a larger number of diagnoses in form of chronic obstructive pulmonary disease, cardiovascular diseases, and diabetes among participants in the intervention group compared to the control group. Furthermore it will be investigated if the proactive action by the general practitioner will be associated with a higher smoking cessation rate at 12 month follow-up.

Conditions

Smoking; Health Behavior; Chronic Disease

Keywords

Health behavior; Chronic disease; Proactive action; General practitioner; Preventive health check; Social inequality in health; Randomised controlled trial

Outcome Measures

Primary Outcomes (2)

• Change from baseline in smoking status at 12 months

  Change in the participants' smoking status from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.

  12 months

• Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes

  Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes at 12 months. Number of chronic diseases are obtained from the general practitioner and from a number of administrative registers.

  12 months

Secondary Outcomes (3)

• Change from baseline in alcohol consumption at 12 months

  12 months

• Change from baseline in physical activity level at 12 months

  12 months

• Change from baseline in perceived stress level at 12 months

  12 months

Study Arms (2)

Proactive action by the general practitioner

EXPERIMENTAL

Proactive action by the general practitioner inviting to preventive health check.

Behavioral: Proactive action by the general practitioner

Control group

NO INTERVENTION

The participants will be treated as usual by the general practitioner.

Interventions

Proactive action by the general practitioner BEHAVIORAL

Individuals allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. Three days before the appointment participants will be reminded by phone about the appointment. At the health check a follow-up consultation will be scheduled. At the follow-up consultation the results of the health check will be reviewed. All participants with abnormal screens at the health check will, depending of the severity, either receive the offer of a referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. This will follow the usual medical standards in general practice. For individuals with abnormal screens or health behavior amenable to intervention at the first health check an additional health check will be scheduled six months after the first health check with a follow-up consultation for review of the results.

Proactive action by the general practitioner

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be 45-64 years old with no formal education beyond secondary school
• Participants must live in Copenhagen
• Participants' general practitioner must be participating in the study

Sponsors & Collaborators

• University of Southern Denmark: lead
• Danish Cancer Society: collaborator

Study Sites (1)

National Institute of Public Health - University of Southern Denmark

Copenhagen, Copenhagen K, 1353, Denmark

Location

Related Publications (2)

• Kamstrup-Larsen N, Broholm-Jorgensen M, Dalton SO, Larsen LB, Thomsen JL, Tolstrup JS. Why do general practitioners not refer patients to behaviour-change programmes after preventive health checks? A mixed-method study. BMC Fam Pract. 2019 Oct 11;20(1):135. doi: 10.1186/s12875-019-1028-2.

  PMID: 31604416 DERIVED

• Kamstrup-Larsen N, Dalton SO, Gronbaek M, Broholm-Jorgensen M, Thomsen JL, Larsen LB, Johansen C, Tolstrup J. The effectiveness of general practice-based health checks on health behaviour and incidence on non-communicable diseases in individuals with low socioeconomic position: a randomised controlled trial in Denmark. BMJ Open. 2019 Sep 18;9(9):e029180. doi: 10.1136/bmjopen-2019-029180.

  PMID: 31537563 DERIVED

MeSH Terms

Conditions

Smoking; Health Behavior; Chronic Disease

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Morten Grønbæk, MD, PhD.

  Centre for Intervention Research in Health Promotion and Disease Prevention - University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Student

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 8, 2013
• Study Start: April 22, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

DK (1)