Quality of Life in a Representative Swedish Population (Normalen)

June 27, 2019 updated by: Eva Haglind

Quality of Life and Body Functions in a Representative Swedish Population

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Göteborg, Sweden, SE41685
        • Göteborg University, Sahlgrenska Academy, Inst Clinical Sciences, Dept Surgery,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Swedish cohort aged 30-89, representatvie for entire Swedish population age 30 -89

Description

Inclusion Criteria:

  • list generated by the equivalent to inland revenue ("Skatteverket", Sweden)

Exclusion Criteria:

  • unable to read and understand Swedish
  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 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"
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sexual health
Time Frame: 12 months
answers to various questions in questionnaire
12 months
gastrointestinal function
Time Frame: 12 months
answers to various questions in questionnaire
12 months
urinary function
Time Frame: 12 months
answers to various questions in questionnaire
12 months
other body functions
Time Frame: 12 months
answers to various questions in questionnaire
12 months
mental health
Time Frame: 12 months
answers to various questions in questionnaire
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • QoL normal Swedes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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