An Observational Study to Evaluate the Quality of Life in Korean Female Participants With Chronic Constipation

July 15, 2013 updated by: Janssen Korea, Ltd., Korea

Health Related Quality of Life in Female Patients With Chronic Constipation

The purpose of this observational study is to investigate health related quality of life (QoL) in Korean female participants with chronic constipation (long term decreased number of or difficulty making bowel movements) having received treatment previously.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a cross-sectional (studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at 1 particular time) observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to investigate the health related QoL in Korean female participants with chronic constipation having received treatment previously by using EQ-5D (EuroQol 5 Dimension), SF-36 (Short Form Health Survey) and PAC-QoL (Patient Assessment of Constipation) questionnaires. The duration of study will be 6 months. Participant's safety will be monitored throughout the study.

Study Type

Observational

Enrollment (Actual)

150

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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Korean female participants with chronic constipation, having received treatment previously for constipation. Participants who have visited Constipation Clinic of AMC or Department of Gastrointestinal for constipation therapy will be selected.

Description

Inclusion Criteria:

-Korean female participants with chronic constipation having received treatment previously

Exclusion Criteria:

  • Male participants
  • Participants with psychological disease (disorders of the mind, thoughts, and behavior)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants With Constipation
Participants with constipation receiving prucalopride will be observed for for the health related quality of life (QoL).
Drug: Prucalopride; observational study
This is an observational study. Korean female participants with chronic constipation and having received treatment previously will be assessed for the health related QoL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D-3L (EuroQol 5 Dimension 3 Level) Quality of life (QoL) Score at Baseline
Time Frame: Baseline
The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 3 levels; 1 indicates better health state (no problems); 3 indicate worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline
EQ-5D-3L (EuroQol 5 Dimension) Quality of life (QoL) Score at Week 1
Time Frame: Week 1
The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 3 levels; 1 indicates better health state (no problems); 3 indicate worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Week 1
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life (QoL) Score at Baseline
Time Frame: Baseline
The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and possible total score range -0.654 to 1.000; higher score indicates a better health state.
Baseline
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life (QoL) Score at Week 1
Time Frame: Week 1
The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and possible total score range -0.654 to 1.000; higher score indicates a better health state.
Week 1
Short Form 36 (SF-36) Quality of life (QoL) Score
Time Frame: Baseline
The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Baseline
Participant Assessment of Constipation Quality of Life (PAC-QoL) Scale Score
Time Frame: Baseline
The PAC-QOL is composed of 28 items grouped into four subscales related to dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Participants rated the severity of each symptom on a five-point scale from 0 (absent) to 4 (very severe), and scores are reported as an average total score or subscale score. The overall and all subscale scores range from 0 to 4, with lower scores indicating better health-related quality of life.
Baseline

Collaborators and Investigators

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

Sponsor

Janssen Korea, Ltd., Korea

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

August 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100894
  • PRUCRC4001

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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