Clinical trial NCT01979107: Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
Official title: Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2013-11-08
Enrollment: 1104
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The study will be conducted at Vesterbro and Amager in Copenhagen, Denmark, and general practitioners with a medical practice in this area will be invited to enter the study. From the patient lists of the participating general practitioners all persons aged 45-64 years will be identified and baseline questionnaires will be mailed to these persons.

The questionnaire information will be entered electronically into the general practitioners electronic chart system using the Danish Quality Unit of General Practice (DAK-E) system. Thus, the questionnaire information will provide the general practitioners with information in the electronic form on health behavior, symptoms and socioeconomic information on all his patients in this age group that would not normally have access to in a systematic way.

Persons who answer the baseline questionnaire and who do not have any formal education will randomly be divided into two groups - one intervention group and one control group.

All persons allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. The health check at the general practitioner includes measurement of weight, height, hip and waist circumference, blood pressure, lung function, blood sugar, total cholesterol, and thyroidal status.

Participants with abnormal screens at the health check will, depending of the severity, either receive the offer of the referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. 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.

Persons allocated to the control group will receive a baseline questionnaire and other than that follow normal procedure in general practice.

At 12 month follow-up questionnaires will be send out to all participants at the intervention group as well as the control group.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-

Primary outcomes:
measure: Change from baseline in smoking status at 12 months
timeFrame: 12 months
measure: Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in alcohol consumption at 12 months
timeFrame: 12 months
measure: Change from baseline in physical activity level at 12 months
timeFrame: 12 months
measure: Change from baseline in perceived stress level at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National Institute of Public Health - University of Southern Denmark
state: Copenhagen K
Study officials:
affiliation: Centre for Intervention Research in Health Promotion and Disease Prevention - University of Southern Denmark
name: Morten Grønbæk, MD, PhD.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.