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

NCT02270229 | Unknown

• 1 other identifier: rev5162014
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Kidney Disease; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (4)

Healthcare providers

PD patients

Primary caregivers of the PD patients

Laboratory personnel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will be performed in a public hospital in northwest Nicaragua. There will be four groups of participants: 1. Healthcare professionals, including physicians, nurses, technicians, and administrators 2. PD patients 3. Primary caregivers of the PD patients 4. Laboratory personnel

You may qualify if:

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

You may not qualify if:

• Being physically unable to participate in an interview of approximately one hour
• Being younger than 18 years of age
• Refusal to participate

Sponsors & Collaborators

• La Isla Foundation: lead
• Baxter Healthcare Corporation: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marvin Gonzalez, MD. MSc.

  CISTA UNAN-Leon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorien Faber, MSc.

CONTACT

+505 2315 1261; dorien@laislafoundation.org

Purvi Patel, JD.

CONTACT

+505 2315 1261; purvi@laislafoundation.org

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Last Updated: October 21, 2014

Record last verified: 2014-10