Chronic Kidney DiseaseNCT02270229
Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua.
An observational study of Chronic Kidney Disease and Peritoneal Dialysis, run by La Isla Foundation.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Peritoneal Dialysis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 1. Participants must be affiliated with the PD program that is under evaluation
Who cannot join
- Being physically unable to participate in an interview of approximately one hour
- Being younger than 18 years of age
- Refusal to participate
Trial locations and contacts
No sites are listed yet.
About this study
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
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare providers | Not described | |
| PD patients | Not described | |
| Primary caregivers of the PD patients | Not described | |
| Laboratory personnel | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Sample collections according to PD patients' appointment times during one week and culturing of samples for 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Isla Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Marvin Gonzalez, MD. MSc., Principal investigator, CISTA UNAN-Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270229
- Sponsor's protocol ID
- rev5162014
- Status last verified
- Oct 2014
- First submitted
- 29 Sep 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua.
- ClinicalTrials.gov ID
- NCT02270229
- Acronym / sponsor ID
- rev5162014
- Conditions
- Chronic Kidney Disease, Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- La Isla FoundationUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Nov 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthcare providers | – | – |
| PD patients | – | – |
| Primary caregivers of the PD patients | – | – |
| Laboratory personnel | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 1. Participants must be affiliated with the PD program that is under evaluation
Key exclusion criteria (3 listed)
- Being physically unable to participate in an interview of approximately one hour
- Being younger than 18 years of age
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of needs of the PD program
Time frame: Hospital visits for the duration of 1 week
This outcome will be measured by filling out a pre-designed checklist based on national and international guidelines, including equipment, material and staffing needs.
Adherence to established protocols on administering PD treatment in the hospital
Time frame: 3 days of observation sessions for the duration of 8 hours
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
Levels of knowledge, attitudes and practices towards PD of healthcare providers, laboratory staff patients and primary caregivers
Time frame: Interviews of each group for the duration of 1 week
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.
Prevalence of peritonitis and causative agents
Time frame: Sample collections according to PD patients' appointment times during one week and culturing of samples for 72 hours
This outcome will be measured by identifying pathogens in patients' dialysate liquid and estimating the overall percentage of patients with peritonitis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marvin Gonzalez, MD. MSc. principal investigator
CISTA UNAN-Leon
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Peritoneal Dialysis, run by La Isla Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorien Faber, MSc. (+505 2315 1261, dorien@laislafoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of needs of the PD program (time frame: Hospital visits for the duration of 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.