NCT00849628

Brief Summary

The purpose of this study is to study factors (drugs, serum concentration of drugs, nutrition, physical activity, demographics, diseases etc.) related to constipation and diarrhea in nursing homes, and the effect of different laxative regimens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

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, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

February 23, 2009

Last Update Submit

July 18, 2016

Conditions

ConstipationDiarrhea

Keywords

AgedPolypharmacyAdverse effectsNursing homes

Outcome Measures

Primary Outcomes (1)

  • Prevalence of constipation

    One year

Study Arms (1)

1

Constipation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents in nursing homes

You may qualify if:

  • Above 60 years old
  • Stayed in nursing homes for more than 8 weeks
  • Informed consent

You may not qualify if:

  • Expected discharge within 2 weeks
  • Organic disorders causing constipation and diarrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innlandet Hospital Trust

Gjøvik, Oppland, 2819, Norway

Location

Related Publications (1)

  • Fosnes GS, Lydersen S, Farup PG. Drugs and constipation in elderly in nursing homes: what is the relation? Gastroenterol Res Pract. 2012;2012:290231. doi: 10.1155/2012/290231. Epub 2012 Feb 29.

    PMID: 22505881RESULT

MeSH Terms

Conditions

ConstipationDiarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Per G Farup, PhD

    Sykehuset Innlandet HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

NO(1)