Peer Support Program in Chronic Kidney Patient

August 13, 2024 updated by: Acibadem University

Examining the Effect of the Peer Support Program Applied to Chronic Kidney Patients on Care Outcomes

The main advantage of patient-to-patient peer counseling is that it benefits both the client and the peer mentors as real and authentic experiences are shared. Since both individuals go through similar experiences, they can share common feelings. Although there are studies in the literature showing the effectiveness of peer support groups in different patient groups, studies on chronic kidney disease patients are limited. There are no studies on the effects of these programs on caregivers. This study will be conducted to examine the effects of peer support program applied to chronic kidney patients on patient outcomes and caregivers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was planned to be conducted with a randomized controlled experimental design to examine the effect of the peer support program applied to Chronic Kidney patients on patient outcomes and caregivers.

Patients diagnosed with Chronic Kidney Disease and receiving haemodialysis (HD) as a renal replacement method constitute the population of the study. In the a priori power analysis performed to calculate the number of subjects, the effect size was taken as 1.3 (d) based on reference studies. Accordingly, it was found that 34 subjects should be included in the calculation for the independent two-sample t-test according to 0.95 power and 0.05 alpha. The sample of the study will consist of 25 intervention and 25 control CKDs who fulfil the inclusion criteria, taking into account the dropout status.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34752
        • Canan Yüksel Acar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion and Exclusion Criteria For Peer Mentor Inclusion Criteria;

  • Speaking Turkish
  • To be literate
  • CKD receiving haemodialysis
  • Volunteering
  • 18 years of age or older
  • Being open to communication and co-operation
  • Not having any psychiatric disorder

For Patient Inclusion Criteria;

  • Speaking Turkish
  • To be literate
  • CKD receiving haemodialysis
  • Volunteering
  • 18 years of age or older
  • Not having any psychiatric disorder

Exclusion criteria for all participants

  • Being under 18 years of age
  • Speaking a language other than Turkish
  • Not being able to use a telephone

Losses to follow-up

  • Experiencing incompatibility with the second peer mentor or client with whom they are paired for peer mentor and peer client
  • Death during the period of intervention or follow-up
  • Withdrawal of patient consent
  • Clinical problems or difficulties attending appointments that hinder follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention group (Peer support)

"Peer mentors" will be determined among the participant patients in accordance with the peer mentor guide selection criteria.

The determined peer mentors will participate in the "Peer Mentor Training Programme".

Implementation of the research; Peer support programme for the intervention group will be carried out for 10 weeks in accordance with the peer guide-client implementation plan Standard follow-up and training programme will be applied to the control group in accordance with the procedures of the institution.

The data collection forms used in the research process will be collected at the stages specified in the study flow plan and data entry will be made by the researcher.
Behavioral: The Peer Support Program
Implementation of the research; Peer support programme for the intervention group will be carried out for 10 weeks in accordance with the peer guide-client implementation plan. Standard follow-up and training programme will be applied to the control group in accordance with the procedures of the institution.
Other: Control group (Standart care)
No intervention will be made by the researcher to the control group. The standard care of the institution will be applied to the patients.
Behavioral: Standart care
The standard care provided by the institution will continue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adaptation to the disease.
Time Frame: The scale will be completed before the intervention and at 3, 7 and 9 weeks.
"End Stage Renal Disease Adaptation Questionnaire (ESRD-AQ)" Total score varies between 0 and 1200. As the score obtained from the scale increases, the level of treatment compliance increases.
The scale will be completed before the intervention and at 3, 7 and 9 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Care
Time Frame: The scale will be completed before the intervention and at 3, 7 and 9 weeks.
"Chronic Dialysis Patients' Self-Care Agency (SCA)" Scores obtained from the scale are between 0-44. As the score decreases, it is evaluated as self-care power is not good.
The scale will be completed before the intervention and at 3, 7 and 9 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient outcomes
Time Frame: The Kt/V value of all patients calculated before the intervention and the change in the value measured 3, 7 and 9 weeks after the intervention will be completed by the researcher.
"Data collection form for patients (The target Kt/V in dialysis patients is between 1.2-1.4. , Kt/V(K - urea dialyzer clearance, t - dialysis time, V - urea volume of distribution))"
The Kt/V value of all patients calculated before the intervention and the change in the value measured 3, 7 and 9 weeks after the intervention will be completed by the researcher.
Caregivers on Care Burden
Time Frame: The scale will be completed by the patients before the intervention and at 9th week.
"Caregiver Burden Scale for family caregivers of hemodialysis patients" Sub-dimension scores, internal consistency of 0.87, 0.70, 0.76, 0.70, 0.70 and 0.53 indicate an increase in care burden.
The scale will be completed by the patients before the intervention and at 9th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Canan Yüksel Acar, Msc, Acibadem Universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Actual)

July 26, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATADEK2023-21/765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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