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Completed

NCT Number: NCT02392923

Quality of Life 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

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Key information

Conditions

Quality of Life

Age range

30 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Göteborg University, Sahlgrenska Academy, Inst Clinical Sciences, Dept Surgery,

Gothenburg, SE41685, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unable to read and understand Swedish
  • no informed consent

Treatment and study plan

Primary outcomes

  1. 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"

Secondary outcomes

  1. sexual health

    Time frame: 12 months

    answers to various questions in questionnaire

  2. gastrointestinal function

    Time frame: 12 months

    answers to various questions in questionnaire

  3. urinary function

    Time frame: 12 months

    answers to various questions in questionnaire

  4. other body functions

    Time frame: 12 months

    answers to various questions in questionnaire

  5. mental health

    Time frame: 12 months

    answers to various questions in questionnaire

Sponsors and collaborators

Lead sponsor

Eva Haglind

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

Quality of Life and Body Functions in a Representative Swedish Population

Acronym: Normalen

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2015
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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