Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua.

Chronic Kidney Disease Clinical Trial

Official title:

Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02270229
• Other study ID #: rev5162014
• Status: Not yet recruiting
• Phase: N/A
• First received: September 29, 2014
• Last updated: October 17, 2014
• Start date: November 2014

Study information

• Verified date: October 2014
• Source: La Isla Foundation
• Contact: Dorien Faber, MSc.
• Phone: +505 2315 1261
• Email: dorien[@]laislafoundation.org
• Is FDA regulated: No
• Health authority: Nicaragua: Ministry of Health (MINSA)
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to develop recommendations to assist in improving the current peritoneal dialysis (PD) program in a Hospital in Chinandega, Nicaragua. This project will consist of a needs assessment, a review of aggregate quantitative patient data from hospital records, and a knowledge, attitudes, and practices (KAP) assessment for medical providers, laboratory technicians, patients and primary caregivers. The final report will be used to obtain funding for the implementation of the recommendations.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants must be affiliated with the PD program that is under evaluation

Exclusion Criteria:

1. Being physically unable to participate in an interview of approximately one hour

2. Being younger than 18 years of age

3. Refusal to participate

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Peritoneal Dialysis
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
La Isla Foundation	Baxter Healthcare Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of needs of the PD program	This outcome will be measured by filling out a pre-designed checklist based on national and international guidelines, including equipment, material and staffing needs.	Hospital visits for the duration of 1 week	No
Primary	Adherence to established protocols on administering PD treatment in the hospital	This outcome will be measured by filling out a validated checklist of steps that need to be performed by the healthcare provider while PD is administered in the Hospital	3 days of observation sessions for the duration of 8 hours	No
Primary	Levels of knowledge, attitudes and practices towards PD of healthcare providers, laboratory staff patients and primary caregivers	This outcome will be measured by administering a questionnaire to the participants of 4 respective groups (healthcare providers, laboratory staff, patients, primary caregivers). The questionnaire will contain sections on (1) demographic information/professional affiliation with the program, (2) knowledge of PD, (3) attitudes towards PD, (4) practices regarding PD, and (5) perceived needs of the program. The levels of knowledge will be classified in four categories: 1) very good, 2) good, 3) regular, 4) poor. Attitudes will be classified as either positive or negative. Practices will be classified as either good or bad.	Interviews of each group for the duration of 1 week	No
Primary	Prevalence of peritonitis and causative agents	This outcome will be measured by identifying pathogens in patients' dialysate liquid and estimating the overall percentage of patients with peritonitis.	Sample collections according to PD patients' appointment times during one week and culturing of samples for 72 hours	No