Quality of Life in a Representative Swedish Population | NCT02392923

Studies
Quality of Life in a Representative Swedish Population

NCT02392923

Sponsor

Eva Haglind

Status

Completed

Last Update Posted

Jun 28, 2019Actual

Enrollment

3,000Actual

Phase

Not provided

Conditions

Quality of Life

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Mar 13, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2019

Last Update Posted Date

Jun 28, 2019Actual

Name	Class
Sahlgrenska University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
sexual health	answers to various questions in questionnaire	12 months
gastrointestinal function	answers to various questions in questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

unable to read and understand Swedish
no informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Haglind	Department of Surgery, Institure for Clinical Sciences, Sahlgernska Academy at Göteborg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Göteborg University, Sahlgrenska Academy, Inst Clinical Sciences, Dept Surgery,		Gothenburg		SE41685	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29730632	Derived	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.