Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling - Full Text View

Sponsored by:	Medical College of Wisconsin
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00677508

Purpose

We propose to develop parent and child disease-specific instruments to assess health related quality of life (HRQoL) in children with constipation and fecal incontinence.

Condition
Constipation Fecal Incontinence

MedlinePlus related topics: Constipation Urinary Incontinence

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	170
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
C FR Children with constipation and fecal incontinence.
C Children with constipation but without fecal incontinence.
P-C FR Parents of children with constipation and/or fecal incontinence.

Detailed Description:

Chronic constipation is a common problem in childhood, accounting for almost 3% of consultations in pediatric practice. In many children constipation is accompanied by overflow soiling (fecal incontinence). This condition often gives rise to behavioral, social, and emotional problems.

We plan to develop a disease-specific instrument to assess HRQoL in children with constipation and fecal incontinence. We hypothesize that HRQoL is worse in children with fecal incontinence compared to children with constipation but no fecal incontinence. The instrument will involve both parent and child self-reporting measures and will enable researchers to evaluate how disease and treatment strategies impact both child and parent perceptions of quality of life. In the long run this will enable physicians to develop a child friendly approach to management of chronic constipation and fecal incontinence.

Eligibility

Ages Eligible for Study:	7 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children will be recruited from the Constipation Clinic at Children's Hospital of Wisconsin.

Criteria

Inclusion Criteria:

Age 7-18 years
Child and parents fluent in English
Constipation: must include 2 or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for a diagnosis of IBS (criteria fulfilled at least once per week for at least 2 months before diagnosis):
1. Two or fewer defecations in the toilet per week
2. At least 1 episode of fecal incontinence per week
3. History of retentive posturing or excessive volitional stool retention
4. History of painful or hard bowel movements
5. Presence of a large fecal mass in the rectum
6. History of large diameter stools that may obstruct the toilet

Exclusion Criteria:

Children with developmental delays and/or who are unable to understand the questionnaires.
Associated chronic disease which may have an impact on quality of life such as cerebral palsy, spine deformity or malformations, learning difficulties, etc.
Child and parents not fluent in English.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677508

Contacts

Contact: Manu Sood, MD

414-266-3690

msood@mcw.edu

Locations

United States, Wisconsin
Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Manu Sood, MD 414-266-3690 msood@mcw.edu
Sub-Investigator: Alan Silverman, PhD
Sub-Investigator: Colin Rudolph, MD, PhD
Sub-Investigator: Margo Kinservik, RN, CPNP
Sub-Investigator: Astrida Kaugars, PhD

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Principal Investigator:

Manu Sood, MD

Medical College of Wisconsin

More Information

Publications:

Treurniet HF, Essink-Bot ML, Mackenbach JP, van der Maas PJ. Health-related quality of life: an indicator of quality of care? Qual Life Res. 1997 May;6(4):363-9.

Brooks RC, Copen RM, Cox DJ, Morris J, Borowitz S, Sutphen J. Review of the treatment literature for encopresis, functional constipation, and stool-toileting refusal. Ann Behav Med. 2000 Summer;22(3):260-7. Review.

Youssef NN, Langseder AL, Verga BJ, Mones RL, Rosh JR. Chronic childhood constipation is associated with impaired quality of life: a case-controlled study. J Pediatr Gastroenterol Nutr. 2005 Jul;41(1):56-60.

Responsible Party:	Medical College of Wisconsin ( Manu Sood/Principal Investigator )
Study ID Numbers:	CHW 05/154
Study First Received:	May 9, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00677508 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:

Constipation
Fecal incontinence
Quality of life
Health related quality of life

Study placed in the following topic categories:

Signs and Symptoms
Fecal Incontinence
Digestive System Diseases
Urologic Diseases
Signs and Symptoms, Digestive
Urination Disorders

Gastrointestinal Diseases
Constipation
Quality of Life
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Urological Manifestations
Signs and Symptoms
Fecal Incontinence
Digestive System Diseases
Urologic Diseases
Signs and Symptoms, Digestive

Urination Disorders
Gastrointestinal Diseases
Constipation
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 07, 2009