Determining the effect of a comprehensive care program on quality of life and respiratory symptoms in patients with cystic fibrosis
Design
Clinical trial with control group, pre- and post-test, members of two randomized groups, without blinding, on 80 patients
Settings and conduct
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 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion: Age ≥ 18 years; Confirmed diagnosis of CF by a physician; Fluency in Persian and literacy; Patient residing in Tehran; 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.
Intervention groups
Control group, intervention group: comprehensive care program
Main outcome variables
Quality of life, respiratory symptoms, self-management
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250727066652N1
Registration date:2025-11-13, 1404/08/22
Registration timing:registered_while_recruiting
Last update:2025-11-13, 1404/08/22
Update count:1
Registration date
2025-11-13, 1404/08/22
Registrant information
Name
Zahra Mansoor Samaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
msamaei-z@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-08-22, 1405/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of a comprehensive care program on quality of life and respiratory symptoms in patients with cystic fibrosis
Public title
Assessment the effect of a comprehensive care program on quality of life and respiratory symptoms in patients with cystic fibrosis
Purpose
Supportive
Inclusion/Exclusion criteria
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.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Nursing and midwifery And Rehabilitation- Tehran University
Street address
6th floor. Central Headquarters of Tehran University of Medical Sciences, at the corner of Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2025-09-17, 1404/06/26
Ethics committee reference number
IR.TUMS.FNM.REC.1404.121
Health conditions studied
1
Description of health condition studied
Cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
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.
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Persian version of the standard and validated Cystic Fibrosis Questionnaire-Revised for ages 14 and older (CFQ-R +14)
Secondary outcomes
1
Description
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.
Timepoint
At the beginning of the study and 8 weeks after the end of the intervention
Method of measurement
Persian version of the standard questionnaire Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)
2
Description
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.
Timepoint
At the beginning of the study and 8 weeks after the end of the intervention
Method of measurement
Persian version of the Partners in Health (PIH) questionnaire
Intervention groups
1
Description
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 and an international 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.
Category
N/A
2
Description
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 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. A short clip prepared in advance, which includes an introduction to the plan, goals, and how the intervention group members will cooperate, is 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 6 weeks. Gradually and based on the designed comprehensive care program, training is placed in the channel every week in the form of clips and text messages for practice and repetition. The intervention (comprehensive care program) is implemented for 6 weeks. Participants in the intervention group are asked to record all their activities in a notebook with details such as the type of activity, date and time on a daily basis, and participants are informed that the notebooks will be returned after the end of the intervention. The format of the notebook is designed in advance by the research team and placed on the channel. During this period, individuals are continuously in contact 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 notebooks are provided to the patients so that the patients can continuously complete it step by step along with the comprehensive care program. After 8 weeks from the start of the program, four more questionnaires are filled out by the intervention group members and planning notebooks are collected from them. In this study, the comprehensive care program intervention will include four main parts: 1. Nutrition: Education on 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 pulmonary function and increase tolerance to daily activities; 3. Psychological care: Education on stress management methods, psychological support, and strategies for dealing with 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 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 program's understandability, acceptability, and applicability, and necessary modifications will be made based on feedback. Data from this pilot will not be used in the final analysis. The program will run for 6 weeks, during which patients will receive and practice the training in stages.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian CF Association
Full name of responsible person
Zahra Mansoor Samaei
Street address
81, Unit 2, 1st Floor, Left Side, Intersection of Gharib St. and Forsat Shirazi St., Gharib St., Western End of Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۵۱
Phone
+98 21 6105 4000
Email
zahrasamaei1380@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Kordi
Street address
6th floor. Central Headquarters of Tehran University of Medical Sciences, at the corner of Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3317885534
Phone
+98 21 5617 3975
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Haleh Jafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Street (East Nusrat), Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
halejafari67@gmil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Mansoor Samaei
Position
MSc Student in Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Street (East Nusrat), Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
zahrasamaei1380@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Mansoor Samaei
Position
MSc Student in Medical surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Street (East Nusrat), Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
zahrasamaei1380@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after anonymizing individuals.
When the data will become available and for how long
The access period will begin 6 months after the publication of the results.
To whom data/document is available
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.
Under which criteria data/document could be used
No other specific condition is required.
From where data/document is obtainable
They can refer to the person who is conducting the sampling.
What processes are involved for a request to access data/document
They can send a message to the mentioned number, and it will be sent to them within a week.