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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Southern Denmark
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Nina Kamstrup-Larsen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01979107
First received: October 25, 2013
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Smoking
Health Behavior
Chronic Disease
Behavioral: Proactive action by the general practitioner

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Change from baseline in smoking status at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in the participants' smoking status from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.

  • Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline in alcohol consumption at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in the participants' alcohol consumption from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.

  • Change from baseline in physical activity level at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in the participants' physical activity level from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.

  • Change from baseline in perceived stress level at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in the participants' perceived stress level measured with perceived stress scale (10 items). Measured with self-reported questionnaires at baseline and at 12 months.


Estimated Enrollment: 1200
Study Start Date: October 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proactive action by the general practitioner
Proactive action by the general practitioner inviting to preventive health check.
Behavioral: Proactive action by the general practitioner

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.

No Intervention: Control group
The participants will be treated as usual by the general practitioner.

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

Ages Eligible for Study:   45 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979107

Contacts
Contact: Nina Kamstrup-Larsen, Cand.scient.san.publ. +45 6550 7818 nkal@si-folkesundhed.dk
Contact: Susanne O. Dalton, MD, PhD +45 35257618 sanne@cancer.dk

Locations
Denmark
National Institute of Public Health - University of Southern Denmark Recruiting
Copenhagen, Copenhagen K, Denmark, 1353
Contact: Nina Kamstrup-Larsen, cand.scient.san.publ.    +45 6550 7818    nkal@si-folkesundhed.dk   
Contact: Susanne O. Dalton, MD, PhD    +45 3525 7618    sanne@cancer.dk   
Principal Investigator: Nina Kamstrup-Larsen, cand.scient.san.publ.         
Principal Investigator: Susanne O. Dalton, MD, PhD         
Sponsors and Collaborators
University of Southern Denmark
Danish Cancer Society
Investigators
Study Director: Morten Grønbæk, MD, PhD. Centre for Intervention Research in Health Promotion and Disease Prevention - University of Southern Denmark
  More Information

No publications provided

Responsible Party: Nina Kamstrup-Larsen, Ph.D. Student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01979107     History of Changes
Other Study ID Numbers: 61110-2095
Study First Received: October 25, 2013
Last Updated: November 1, 2013
Health Authority: Denmark:The Centre for Intervention Research in Health Promotion and Disease Prevention
Denmark: National Institute of Public Health - University of Southern Denmark

Keywords provided by University of Southern Denmark:
Health behavior
Chronic disease
Proactive action
General practitioner
Preventive health check
Social inequality in health
Randomised controlled trial

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014