Quality of Life in a Representative Swedish Population

Quality of Life Clinical Trial

— Normalen  

Official title:

Quality of Life and Body Functions in a Representative Swedish Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392923
• Other study ID #: QoL normal Swedes
• Status: Completed
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: June 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 89 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• unable to read and understand Swedish

• no informed consent

Related Conditions & MeSH terms

• Quality of Life

Locations

Country	Name	City	State
Sweden	Göteborg University, Sahlgrenska Academy, Inst Clinical Sciences, Dept Surgery,	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Eva Haglind	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	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	sexual health	answers to various questions in questionnaire	12 months
Secondary	gastrointestinal function	answers to various questions in questionnaire	12 months
Secondary	urinary function	answers to various questions in questionnaire	12 months
Secondary	other body functions	answers to various questions in questionnaire	12 months
Secondary	mental health	answers to various questions in questionnaire	12 months