Peer ReviewNCT06555718
Peer Support Program in Chronic Kidney Patient
A study testing The Peer Support Program and Standart care in people with Peer Review and Hemodialysis Complication, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peer Review, Hemodialysis Complication, Nurse's Role
- What is being tested?
- The Peer Support Program and Standart care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2024to 30 Jan 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- The Peer Support Program, Standart care
- Keywords
- Peer sport, nursing, hemodialysis
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Peer Support ProgramBehavioural
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.
Standart careBehavioural
The standard care provided by the institution will continue.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Peer support) | Other | "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. Receives: Behavioral: The Peer Support Program |
| Control group (Standart care) | Other | No intervention will be made by the researcher to the control group. The standard care of the institution will be applied to the patients. Receives: Behavioral: Standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation to the disease.
"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.
Measured: The scale will be completed before the intervention and at 3, 7 and 9 weeks.
Secondary outcomes (1)
Self-Care
"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.
Measured: The scale will be completed before the intervention and at 3, 7 and 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start11 Jan 2024
- Primary completion26 Jul 2024
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer ReviewStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will start after obtaining official institutional permissions. The researcher will examine the profile of patients receiving treatment at the dialysis center. After this stage, the following steps will be followed
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan Yüksel Acar, Msc, Principal investigator, Acibadem Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555718
- Sponsor's protocol ID
- ATADEK2023-21/765
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of the Peer Support Program Applied to Chronic Kidney Patients on Care Outcomes
- ClinicalTrials.gov ID
- NCT06555718
- Acronym / sponsor ID
- ATADEK2023-21/765
- Keywords
- Peer sport, nursing, hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 15 Aug 2024 (actual)
- 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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will start after obtaining official institutional permissions. The researcher will examine the profile of patients receiving treatment at the dialysis center. After this stage, the following steps will be followed
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Peer support) | Other | Behavioral: The Peer Support Program"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. |
| Control group (Standart care) | Other | Behavioral: Standart careNo intervention will be made by the researcher to the control group. The standard care of the institution will be applied to the patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Peer Support ProgramImplementation 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. | Behavioural | Intervention group (Peer support) |
| Standart careThe standard care provided by the institution will continue. | Behavioural | Control group (Standart care) |
Primary outcome
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.
1 secondary outcome
Self-Care
Time frame: The scale will be completed before the intervention and at 3, 7 and 9 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Canan Yüksel Acar, Msc principal investigator
Acibadem Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Peer Support Program and Standart care in people with Peer Review and Hemodialysis Complication, run by Acibadem University at 1 site in Turkey (Türkiye).
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 0 inclusion and 8 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 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation to the disease. (time frame: The scale will be completed before the intervention and at 3, 7 and 9 weeks.). 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 15 Aug 2024.