Protocol summary
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Study aim
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Determining the effect of mobile-based diet plan training on constipation management and quality of life of peritoneal dialysis patients
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Design
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Phase 3 randomized clinical trial on 30 patients, two arms with active control, Single-blind. Block randomization with random sequence generation software
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Settings and conduct
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The present study is a double-blind clinical trial that has been compiled using the criteria of the 2010 concert checklist.
This study will be performed as a pre-test and post-test with an intervention and control group in Shiraz University of Medical Sciences Peritoneal Dialysis Centers in 2021.
physicians, evaluators, educators, statistical analyzers are blinded in this study.
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Participants/Inclusion and exclusion criteria
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inclusion criteria: 30 patients (+18 y) with symptoms of constipation at the time of screening and scoring 1 and 2 on the Bristol chart.
Exclusion criteria: current use of Constipation-Causing Medications, pregnancy or lactation, history of alcohol use or drug abuse, history of thyroid disease in oneself and family, dementia, colitis, irritable bowel syndrome.
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Intervention groups
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Intervention group for 4 weeks, mobile diet training + placebo;
C-Lax placebo, administered twice daily
5 Session 10-minute In the form of Meetings in absentia (WhatsApp software), on days 1-5.
Educational content: Definition of peritoneal dialysis, constipation, the importance of constipation and its complications in patients undergoing peritoneal dialysis, the diet of patients undergoing peritoneal dialysis (fruits, vegetables, and water), and appropriate activities to relieve constipation.
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Main outcome variables
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Constipation status before and after the intervention, assessment with PAC-SYM questionnaire and Bristol chart; Quality of life before and after the interventions, assessment with the PAC-QOL questionnaire.
General information
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Reason for update
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Writing problems
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200707048035N1
Registration date:
2021-07-02, 1400/04/11
Registration timing:
prospective
Last update:
2021-07-18, 1400/04/27
Update count:
1
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Registration date
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2021-07-02, 1400/04/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-07-11, 1400/04/20
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Expected recruitment end date
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2021-08-11, 1400/05/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the influence of Mobile-Based dietary program education on Constipation Management and quality of life of Peritoneal dialysis patients
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Public title
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Mobile-Based dietary program education on Constipation Management and quality of life
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients older than 18 years, treated with peritoneal dialysis in Shiraz University of Medical Sciences Peritoneal Dialysis Centers in 2021
Ability to read and write
Access telecommunications facilities such as telephones or cell phones.
Get a score of 1 and 2 on the Bristol chart.
Informed consent to enter the study.
Patients with symptoms of constipation at the time of screening (average <3 spontaneous bowel movements per week + symptoms related to constipation in at least 25% of bowel movements).
Exclusion criteria:
Current use of medications known to have constipation effects (such as narcotics, calcium channel blockers, tricyclic antidepressants, and anti-parasympathetic drugs), pregnancy or lactation, history of alcohol or drug abuse, and no history of thyroid disease And family; and other significant or uncontrolled illnesses (patients with one of the following conditions: dementia, colitis, irritable bowel syndrome). If the patient undergoes a kidney transplant during the intervention, or does not want to continue participating in the study, he will be excluded from the study.
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, we will use the block randomization method. Random sequence generation software is also used for randomization. After obtaining written consent, patients will be randomly assigned to blocks of 6 (including 3 participants in the diet + placebo group and 3 participants in the standard treatment group) at a ratio of 1: 1.
For concealment, we use random allocation concealment, so that the assigned group is not known before the individual is assigned.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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C-lax and placebo tablets made by Shiraz School of Pharmacy with similar appearance will be packed in medicine boxes with a similar appearance and will be delivered with the Researcher's assistance. Patients who meet the inclusion criteria from the physician's point of view are selected for inclusion in the study with the help of the Researcher's assistance, And based on the specified random sequence, they are divided into two groups made in WhatsApp software and will receive the bottle with the symbol A or B. Patient education is performed by the principal investigator, patient assessment by the treating physician, and data collection is performed by the Researcher's assistance. All of these people, plus the person performing the statistical analysis, will be unaware of whether A or B is related to the drug or placebo until the end of the study and data analysis.
Patients are treated at home and will not be unaware of the allocation of study groups due to their training, but will be unaware of whether A or B is related to medication or placebo until the end of the study.
Peritoneal dialysis is performed at home and diet training in the intervention group will be individual.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-04-20, 1400/01/31
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Ethics committee reference number
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IR.SUMS.REC.1400.050
Health conditions studied
1
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Description of health condition studied
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constipation
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ICD-10 code
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K59.0
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ICD-10 code description
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Constipation
Primary outcomes
1
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Description
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Severe constipation on the Bristol chart and , Patient Assessment of Constipation and Symptoms
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Timepoint
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Before and after the intervention
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Method of measurement
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Bristol chart, Patient Assessment of Constipation and Symptoms
2
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Description
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Quality of life score in the Constipation Patient Quality of Life Assessment Questionnaire
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Timepoint
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Before and after the intervention
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Method of measurement
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Patient Assessment of Constipation-Quality of Life
Secondary outcomes
1
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Description
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The amount of fiber in the diet
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Timepoint
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Before and after the intervention
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Method of measurement
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24-hour food recall questionnaire
Intervention groups
1
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Description
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The intervention group will be held for 4 weeks by holding training sessions in absentia and through the membership of group members in groups formed in WhatsApp software via mobile. Training sessions for the case group will include 5-10 minute sessions that will take place on days 5-1. Educational content will include the definition of peritoneal dialysis, constipation, the importance of constipation and its complications in patients undergoing peritoneal dialysis, the diet of patients undergoing peritoneal dialysis (fruits, vegetables, and water), and appropriate activities to relieve constipation. Questions and answers, group discussions, and educational videos will be provided through WhatsApp software. Patients will then be reviewed and followed up for 3 weeks in terms of adherence to the educational content provided, diet consumed and how to consume the recommended items and the current situation, and appropriate feedback will be provided if needed. In addition to training, the case group will be given a placebo. The above-mentioned placebo is two corn starch tablets (after preparation by Shiraz University of Medical Sciences Pharmaceutical Company) with the brand name C-Lax, which patients will receive twice a day, similar to the control group. The placebo will be similar in color, shape, and weight to the C-Lax tablet made by the Dineh Iran company.
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Category
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Behavior
2
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Description
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Standard treatment group: This group will be treated twice a day as usual with C-Lax made by Dineh Iran Company.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data is potentially shareable after unidentified individuals.
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When the data will become available and for how long
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Access period starts 6 months after the results are published.
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To whom data/document is available
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It will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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The results of the study can be used to complete the research of academic researchers on dialysis patients and patients with constipation.
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From where data/document is obtainable
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In order to access the results of the studies, it is possible to contact Mr. Javad Rajabzadeh (listed in the Iranian Clinical Trial Registration Center) through various communication channels.
Email address: javadrajabzade888@gmail.com
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What processes are involved for a request to access data/document
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Six months after the publication of the results, the applicant can send a request for the use of data and documents through the communication channels listed in the Iranian Clinical Trial Registration, and an appropriate response will be provided to their request at least three months from the date of application.
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Comments
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