Clincosm LogoSign in Get a demo

Normalen: Quality of Life in a Representative Swedish Population

Sponsor
Eva Haglind (Other)
Overall Status
Completed
CT.gov ID
NCT02392923
Collaborator
Sahlgrenska University Hospital, Sweden (Other)
3,000
Enrollment
1
Location
17
Duration (Months)
176.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cohort descriptive study of quality of life and body functions in a reference population of Swedish inhabitants from age 30 to age 89. The population was selected to be representative for the general Swedish population and 500 in each 10 year group, 250 men and 250 women.

The population is contacted and asked for informed consent, whereafter a questionnaire of about 200 questions, used in a number of studies in clinical studies and trials, are sent out.

The results will be used as reference values to our patient cohorts

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Individuals contacted by letter with information about the study and it's aim. The next step is a telephone contact from the study secretariate where the person can ask for more detailed information and put questions to the reserach nurse. The call leads up to a question to the person, if the questionnaire can be sent. If yes, the questionnaire is posted includeing the consent form and an pre-paid return envelope. After two weeks a thank you/reminder letter is sent out, and if no reply one more phone call is made two weeks further on.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Quality of Life and Body Functions in a Representative Swedish Population
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Oct 1, 2015
    Actual Study Completion Date :
    Nov 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. quality of life [12 months]

      answers to specific questions in questionnaire The time frame of most questions is "How would you rate your quality fo life during the last month"

    Secondary Outcome Measures

    1. sexual health [12 months]

      answers to various questions in questionnaire

    2. gastrointestinal function [12 months]

      answers to various questions in questionnaire

    3. urinary function [12 months]

      answers to various questions in questionnaire

    4. other body functions [12 months]

      answers to various questions in questionnaire

    5. mental health [12 months]

      answers to various questions in questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • list generated by the equivalent to inland revenue ("Skatteverket", Sweden)
    Exclusion Criteria:

    • unable to read and understand Swedish

    • no informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Göteborg University, Sahlgrenska Academy, Inst Clinical Sciences, Dept Surgery, Göteborg Sweden SE41685

    Sponsors and Collaborators

    • Eva Haglind
    • Sahlgrenska University Hospital, Sweden

    Investigators

    • Principal Investigator: Eva Haglind, Department of Surgery, Institure for Clinical Sciences, Sahlgernska Academy at Göteborg University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eva Haglind, Professor, Consultant Surgeon, Göteborg University
    ClinicalTrials.gov Identifier:
    NCT02392923
    Other Study ID Numbers:
    • QoL normal Swedes
    First Posted:
    Mar 19, 2015
    Last Update Posted:
    Jun 28, 2019
    Last Verified:
    Jun 1, 2019
    Keywords provided by Eva Haglind, Professor, Consultant Surgeon, Göteborg University
    health related quality of life

    Study Results

    No Results Posted as of Jun 28, 2019