NCT02392923

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 18, 2014

Last Update Submit

June 27, 2019

Conditions

Quality of Life

Keywords

health related quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • sexual health

    12 months

  • gastrointestinal function

    12 months

  • urinary function

    12 months

  • other body functions

    12 months

  • mental health

    12 months

Eligibility Criteria

Age30 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • unable to read and understand Swedish
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gothenburg, SE41685, Sweden

Location

Related Publications (1)

  • Bock D, Angenete E, Gonzales E, Heath J, Haglind E. Assessing health, quality of life and urogenital function in a sample of the Swedish general population: a cross-sectional study. BMJ Open. 2018 May 5;8(5):e021974. doi: 10.1136/bmjopen-2018-021974.

    PMID: 29730632DERIVED

Study Officials

  • Eva Haglind

    Department of Surgery, Institure for Clinical Sciences, Sahlgernska Academy at Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Consultant Surgeon

Study Record Dates

First Submitted

June 18, 2014

First Posted

March 19, 2015

Study Start

June 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

June 28, 2019

Record last verified: 2019-06

Locations

SE(1)