Kidney TransplantationNCT06195696
Illness Perception and Coping in Kidney Transplant Recipients: a Mixed Research Based on Common Sense Model
An observational study of Kidney Transplantation and Illness Perception and Coping, run by Wu Jiangxue.
Trial summary
The goal of this observational study is to learn about the current status of illness perception and the distribution of coping styles in kidney transplant recipients. The main question clarifies the current status and experience of illness perception in post-transplant patients with different coping styles, and aims… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Kidney Transplantation, Illness Perception and Coping
- What is being tested?
- employs questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Recipients who underwent kidney transplantation at a tertiary hospital in Zunyi between January 01, 2024 and December 2024 were selected for the study using a convenience sampling method.
Who may be able to join
- Patients between the ages of 18 and 55 who have received a kidney transplant and have been discharged from the hospital for at least 3 months. Patients must have basic communication skills and be willing to participate in the survey voluntarily by signing the informed consent form.
Who cannot join
- Patients with a history of other malignant tumors; (ii) patients who are participating in other clinical trials or related treatments; (iii) patients with other serious physical diseases; and (iv) kidney transplant patients with psychiatric disorders, serious cognitive impairment, or speech defects that prevent them from cooperating.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this observational study is to learn about the current status of illness perception and the distribution of coping styles in kidney transplant recipients. The main question clarifies the current status and experience of illness perception in post-transplant patients with different coping styles, and aims to provide a reference basis for intervention of illness perception in kidney transplant patients, with the aim of improving their current status of illness perception, optimizing their awareness of treatment management and self-care behaviors, and perfecting the modern medical service system. Participants will describe the main tasks participants will be asked to do.
Read the detailed description
Aims:This study explores the current status of illness perception and the distribution of coping styles in kidney transplant recipients, clarifies the current status and experience of illness perception in post-transplant patients with different coping styles, and aims to provide a reference basis for intervention of illness perception in kidney transplant patients, with the aim of improving their current status of illness perception, optimizing their awareness of treatment management and self-care behaviors, and perfecting the modern medical service system.Methods:This study is based on the Common Sense Model (CSM), which is the most widely used theory for explaining and predicting disease adaptation and patient self-management behaviors.This study utilizes a mixed-methods research design, specifically the interpretive sequence design, consisting of two phases. The first phase is a quantitative study that employs a questionnaire to investigate the current state of illness perception and the distribution of coping styles in kidney transplant recipients, and to explore the differences in illness perception between positive coping and negative coping patients after kidney transplantation; The second phase involves a descriptive qualitative study that utilizes face-to-face, semi-structured, in-depth interviews to investigate the causes of differences in illness perceptions of different coping styles in kidney transplant recipients who experience idiosyncrasies.
- Being tested
- employs questionnaires
- Keywords
- illness perception, common sense model, kidney transplant, mixed research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
employs questionnairesBehavioural
Also called involves a descriptive qualitative study
The first phase is a quantitative study that employs a questionnaire to investigate the current state of illness perception and the distribution of coping styles in kidney transplant recipients, and to explore the differences in illness perception between positive coping and negative coping patients after kidney transplantation; The second phase involves a descriptive qualitative study that utilizes face-to-face, semi-structured, in-depth interviews to investigate the causes of differences in illness perceptions of different coping styles in kidney transplant recipients who experience idiosyncrasies.
What is being measured
The primary outcome is the main question the study is designed to answer.
the current state of illness perception
Using The general information questionnaire to measure
Measured: 2024.01-2024.12
the distribution of coping styles in kidney transplant recipients
Using Simplified Coping Style Questionnaire to measure
Measured: 2024.01-2024.12
the causes of differences in illness perceptions of different coping styles
UsingThe Brief Illness Perception Questionnaire to measure
Measured: 2024.01-2024.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Jiangxue
- Sponsor type
- University, hospital or other
- Collaborators
- Zunyi Medical College
- Responsible party
- Sponsor-investigator, Wu Jiangxue, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195696
- Sponsor's protocol ID
- KLL-2023-466
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illness Perception and Coping in Kidney Transplant Recipients: a Mixed Research Based on Common Sense Model
- ClinicalTrials.gov ID
- NCT06195696
- Acronym / sponsor ID
- KLL-2023-466
- Keywords
- illness perception, common sense model, kidney transplant, mixed research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Wu JiangxueUniversity, hospital or other
- Collaborators
- Zunyi Medical College
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jan 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 goal of this observational study is to learn about the current status of illness perception and the distribution of coping styles in kidney transplant recipients. The main question clarifies the current status and experience of illness perception in post-transplant patients with different coping styles, and aims to provide a reference basis for intervention of illness perception in kidney transplant patients, with the aim of improving their current status of illness perception, optimizing their awareness of treatment management and self-care behaviors, and perfecting the modern medical service system. Participants will describe the main tasks participants will be asked to do.
Detailed description
Aims:This study explores the current status of illness perception and the distribution of coping styles in kidney transplant recipients, clarifies the current status and experience of illness perception in post-transplant patients with different coping styles, and aims to provide a reference basis for intervention of illness perception in kidney transplant patients, with the aim of improving their current status of illness perception, optimizing their awareness of treatment management and self-care behaviors, and perfecting the modern medical service system.Methods:This study is based on the Common Sense Model (CSM), which is the most widely used theory for explaining and predicting disease adaptation and patient self-management behaviors.This study utilizes a mixed-methods research design, specifically the interpretive sequence design, consisting of two phases. The first phase is a quantitative study that employs a questionnaire to investigate the current state of illness perception and the distribution of coping styles in kidney transplant recipients, and to explore the differences in illness perception between positive coping and negative coping patients after kidney transplantation; The second phase involves a descriptive qualitative study that utilizes face-to-face, semi-structured, in-depth interviews to investigate the causes of differences in illness perceptions of different coping styles in kidney transplant recipients who experience idiosyncrasies.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Recipients who underwent kidney transplantation at a tertiary hospital in Zunyi between January 01, 2024 and December 2024 were selected for the study using a convenience sampling method.
Key inclusion criteria (1 listed)
- Patients between the ages of 18 and 55 who have received a kidney transplant and have been discharged from the hospital for at least 3 months. Patients must have basic communication skills and be willing to participate in the survey voluntarily by signing the informed consent form.
Key exclusion criteria (1 listed)
- Patients with a history of other malignant tumors; (ii) patients who are participating in other clinical trials or related treatments; (iii) patients with other serious physical diseases; and (iv) kidney transplant patients with psychiatric disorders, serious cognitive impairment, or speech defects that prevent them from cooperating.
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 |
|---|---|---|
| employs questionnairesAlso: involves a descriptive qualitative studyThe first phase is a quantitative study that employs a questionnaire to investigate the current state of illness perception and the distribution of coping styles in kidney transplant recipients, and to explore the differences in illness perception between positive coping and negative coping patients after kidney transplantation; The second phase involves a descriptive qualitative study that utilizes face-to-face, semi-structured, in-depth interviews to investigate the causes of differences in illness perceptions of different coping styles in kidney transplant recipients who experience idiosyncrasies. | Behavioural | – |
Primary outcome
the current state of illness perception
Time frame: 2024.01-2024.12
Using The general information questionnaire to measure
the distribution of coping styles in kidney transplant recipients
Time frame: 2024.01-2024.12
Using Simplified Coping Style Questionnaire to measure
the causes of differences in illness perceptions of different coping styles
Time frame: 2024.01-2024.12
UsingThe Brief Illness Perception Questionnaire to measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Illness Perception and Coping, run by Wu Jiangxue.
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 1 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 8 Jan 2024. 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 Liu Yang, master (13727017586, 1185877870@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the current state of illness perception (time frame: 2024.01-2024.12). The study lists 3 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 8 Jan 2024.