Protocol summary
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Study aim
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Determining the effect of a comprehensive care program on quality of life and respiratory symptoms in patients with cystic fibrosis
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Design
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Clinical trial with control group, pre- and post-test, members of two randomized groups, without blinding, on 80 patients
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Settings and conduct
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The research environment will be the Iranian CF Association. The entire work will be done in a virtual environment. To prevent data contamination, sampling will be done first from the control group. After sampling from the control group, gradually and based on the designed comprehensive care program, the training will be provided to the intervention group for practice and repetition virtually every week. The intervention (a comprehensive care program that includes nutrition, exercise and breathing exercises, psychological and social care) will be implemented for 8 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion: Age ≥ 18 years; Confirmed diagnosis of CF by a physician; Fluency in Persian and literacy; Owning a smartphone and being able to use it; Not participating in similar care programs in the past 6 months; Providing written informed consent to participate in the study.
Exclusion: Having a diagnosed severe psychiatric illness (such as schizophrenia or active bipolar disorder); Having severe chronic illnesses (severe organ failure and active cancer); History of lung transplantation.
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Intervention groups
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Control group, intervention group: comprehensive care program
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Main outcome variables
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Quality of life, respiratory symptoms, self-management
General information
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Reason for update
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Residence in Tehran was removed from the inclusion criteria because the number of patients was limited, and to ensure sufficient sampling, samples from each city were included in the study. The start and end times of sampling were changed because sampling was not performed before receiving the code from the system, and after receiving the code, sampling began several months later due to a change in one of the secondary outcome measurement tools. The license for the clinical symptom measurement tool was revoked due to sanctions, and based on the suggestion of the tool's designer, it was replaced with an older and similar tool.
The method of randomizing the groups was also changed due to the small sample size available, and the previous randomization method is discussed below.
The implementation method of planner was changed to checklists due to the lack of in-person access to some patients.
Each of the items mentioned was edited in the relevant section.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20250727066652N1
Registration date:
2025-11-13, 1404/08/22
Registration timing:
prospective
Last update:
2026-07-20, 1405/04/29
Update count:
1
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Registration date
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2025-11-13, 1404/08/22
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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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2025-11-22, 1404/09/01
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Expected recruitment end date
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2026-10-22, 1405/07/30
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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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Assessment the effect of a comprehensive care program on quality of life and respiratory symptoms in patients with cystic fibrosis
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Public title
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Assessment the effect of a comprehensive care program on quality of life and respiratory symptoms in patients with cystic fibrosis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
- Greater age equal to 18 years;
- A confirmed diagnosis of CF by a physician;
- Fluency in Persian and ability to read and write;
- The patient resides in Tehran;
- Having a smartphone and being able to use it;
- Not participating in similar care programs in the past 6 months;
- Giving written informed consent to participate in the study.
Exclusion criteria:
- Having a diagnosed severe psychiatric illness (such as schizophrenia or active bipolar disorder);
- Having severe chronic diseases (severe vital organ failure and active cancer);
- History of lung transplantation.
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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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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In the first stage, patients will be selected from among those who refer to the Cystic Fibrosis (CF) Association who meet the inclusion criteria.
Then, participants will be divided into two control and intervention groups using a block randomization method, such that the number of people in both groups will be equal. For this purpose, blocks of four will be used; so that the letter A will represent the intervention group and the letter B will represent the control group.
In each block, two people will be assigned to group A and two people to group B. All possible combinations of the sequence of letters A, A, B, and B, which includes the following six cases, will be considered.
1. AABB
2. ABBA
3. ABAB
4. BBAA
5. BAAB
6. BABA
Then, the numbers 1 to 6 will be written on cards and placed in a container. To determine the order of allocation, one number will be randomly removed from the container each time. For example, if the number 2 is chosen, the order of sample allocation will be according to the second combination, i.e. (ABBA); that is, the first and fourth people will be in the intervention group and the second and third people will be in the control group.
This process will continue until the required number of samples is completed. To ensure randomization of allocation and eliminate bias, numbered cards will be placed in sealed envelopes so that the researcher does not know their order. After each withdrawal, the card will be returned to the container. In total, 18 numbers will be randomly drawn from the container and the resulting sequence of numbers will determine the final order of the blocks.
Considering the conditions in the clinic, the random sampling method was changed as follows: The allocation of participants to study groups was done using the even and odd-numbered allocation method, so that people with even numbers on the patient list were placed in the intervention group and people with odd numbers were placed in the control group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2025-09-17, 1404/06/26
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Ethics committee reference number
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IR.TUMS.FNM.REC.1404.121
Health conditions studied
1
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Description of health condition studied
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Cystic fibrosis
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ICD-10 code
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E84
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ICD-10 code description
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Cystic fibrosis
Primary outcomes
1
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Description
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Determining and comparing the average quality of life score of adult patients with cystic fibrosis in the intervention and control groups, before and after implementing a comprehensive care program.
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Timepoint
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At the beginning of the study and 8 weeks after the intervention
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Method of measurement
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Persian version of the standard and validated Cystic Fibrosis Questionnaire-Revised for ages 14 and older (CFQ-R +14)
Secondary outcomes
1
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Description
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Determining and comparing the mean clinical symptom scores of adult patients with cystic fibrosis in the intervention and control groups, before and after implementing a comprehensive care program.
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Timepoint
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At the beginning of the study and 8 weeks after the end of the intervention
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Method of measurement
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Persian version of the standard questionnaire for total symptom score
2
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Description
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Determining and comparing the average self-management score of adult patients with cystic fibrosis in the intervention and control groups, before and after implementing a comprehensive care program.
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Timepoint
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At the beginning of the study and 8 weeks after the end of the intervention
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Method of measurement
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Persian version of the Partners in Health (PIH) questionnaire
Intervention groups
1
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Description
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Control group: Control group: Members of the Iranian CF Association have a channel and information group on the ETA messenger; in this environment, patients and CF specialists are members; patients visit online and ask their questions to specialists or other members of the organization; for this purpose, to prevent data contamination, sampling is first done for the control group and then for the intervention group. Sampling and intervention are carried out virtually on a shared domestic messenger (due to restrictions on international Internet access). In order to facilitate the work for patients, to consider respiratory problems and limitations resulting from the disease in their daily activity, to save time, and to prevent the imposition of travel costs on patients, the plan is implemented virtually. On the other hand, the intervention content is located on a special channel for the intervention group, and there is continuous access to the channel content and training for members of the intervention group. After obtaining informed consent from the control group, they fill out four electronic questionnaires (demographic information, quality of life, respiratory symptoms, and self-management) in two stages with an 8-week interval; the control group receives routine care during this period, and after the sampling from the control group is completed, the sampling from the intervention group begins.
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Category
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N/A
2
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Description
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Intervention group: After obtaining informed consent, all members of the intervention group become members of a shared messenger between members in the "information channel" that the research team has designed for the explanations of the intervention group; the channel settings are such that participants cannot see the channel members; only the channel admin, i.e. the researcher, has the ability to send messages in the channel, and if participants have any questions, they should ask the channel admin privately. The above is done to maintain the confidentiality of the sample information and to avoid influencing each other and the results of the research. Pre-prepared introductory messages, which include introducing the plan, goals, and how the intervention group members will cooperate, are placed in the channel. After that, four electronic questionnaires (demographic information, quality of life, respiratory symptoms, and self-management) are filled out by the intervention group members before the intervention. The intervention (comprehensive care program) is implemented for 8 weeks. Gradually and based on the designed comprehensive care program, training is placed in the channel every week in the form of PDFs, infographics, text messages, etc. for practice and repetition. Participants in the intervention group are asked to record all their activities in daily checklists with details such as the type of activity, date, and time. The format of the checklists is designed in advance by the research team and is placed in the channel step by step. During this period, individuals are continuously in touch with the project implementer to ask their questions and ambiguities through messengers; to ensure the correct implementation of the intervention, the researcher contacts all samples every week and, on the other hand, planning checklists are provided to the patients so that the patients can continuously complete it step by step along with the comprehensive care plan. After 8 weeks from the start of the program, four more questionnaires are filled out by the intervention group members and planning booklets are collected from them. In this study, the comprehensive care plan intervention will include four main parts: 1. Nutrition: Teaching the principles of proper nutrition for cystic fibrosis patients with an emphasis on the specific needs of these patients (such as calories, protein, vitamins); 2. Exercise and breathing exercises: Providing an exercise program including aerobic exercises and special breathing exercises to improve lung function and increase tolerance to daily activities; 3. Psychological care: Teaching stress management methods, psychological support, and coping strategies for anxiety and depression related to the disease; 4. Social care: Providing guidance for social support, increasing social interactions, and using support resources in the community. The content of this program will be developed based on a systematic review of current scientific literature, internationally recognized guidelines, and in consultation with several experts in the field of cystic fibrosis. To confirm the validity of the content, the draft of the program will be reviewed by 5 to 7 experts and the CVR and CVI indices will be calculated. Also, a small pilot test will be conducted with the presence of 5 to 10 patients to assess the understandability, acceptability, and applicability of the program, and necessary modifications will be made based on feedback. The data from this pilot will not be used in the final analysis.
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Category
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Rehabilitation
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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Tehran 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 anonymizing individuals.
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When the data will become available and for how long
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The access period will begin 6 months after the publication of the results.
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To whom data/document is available
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The data will not only be available to researchers working at academic and scientific institutions, but individuals employed in industry can also apply to access them.
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Under which criteria data/document could be used
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No other specific condition is required.
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From where data/document is obtainable
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They can refer to the person who is conducting the sampling.
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What processes are involved for a request to access data/document
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They can send a message to the mentioned number, and it will be sent to them within a week.
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Comments
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