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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02482896
Other study ID # SJ-421
Secondary ID
Status Recruiting
Phase N/A
First received June 1, 2015
Last updated October 6, 2016
Start date February 2016
Est. completion date December 2019

Study information

Verified date June 2016
Source Region Sjælland
Contact Randi Jepsen, PhD, MSc, RN
Phone +4556516856
Email rjep@regionsjaelland.dk
Is FDA regulated No
Health authority Denmark: The National Committee on Health Research Ethics
Study type Observational

Clinical Trial Summary

The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent than in the urban areas of the country. The population study aims at examining complexities of environmental, hereditary, lifestyle, and social factors as determinants and predisposing factors for morbidity, health, and quality of life. The study will cover physical, mental, and social dimensions and examine family patterns and subgroups. The study will provide baseline information for later follow-up.


Recruitment information / eligibility

Status Recruiting
Enrollment 25000
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Both
Age group N/A to 110 Years
Eligibility Inclusion Criteria:

- Individuals registered in Lolland or Guldborgsund municipality

Exclusion Criteria:

- Adults with incapacity guardianship

- Incapacity to give informed consent

- Individuals with address protection

- Severe physical immobility

- Non-Danish and Non-English speaking

Study Design

Observational Model: Family-Based, Time Perspective: Cross-Sectional


Locations

Country Name City State
Denmark The Lolland-Falster Health Study Nykøbing Falster Region Sjaelland

Sponsors (3)

Lead Sponsor Collaborator
Region Sjælland Guldborgsund Municipality, Denmark, Lolland Municipality, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health Self-administered questionnaires, clinical examination, and biospecimen Cross-sectional, measured once No
Secondary Morbidity Self-administered questionnaires, clinical examination, and biospecimen Cross-sectional, measured once No
Secondary Risk factors Self-administered questionnaires, clinical examination, and biospecimen Cross-sectional, measured once No
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