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IRCT20140412017237N13 IRCT 2021-09-24 Gorgan University of Medical Sciences Continuous care and self-efficacy of patients with COPD Comparison of the effect of continuous care model and routine care on self-efficacy of patients with chronic obstructive pulmonary disease 2021-09-21 anticipated 84 Complete https://irct.ir/trial/52079 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: By referring to the Randomization.com website and using the block randomization method (block of size 4), a list of random numbers is produced by one of the members of the research team who will not aware of the process of entering the groups (sample size of 84 people, in two groups A - B). Then the letters A and B will be written on the cards and placed in the sequentially numbered, sealed, opaque envelopes (1 to 84). After checking the inclusion criteria, the participants will receive the relevant envelope, respectively, and they will be allocated into two intervention (A) and control (B) groups according to the card in the envelopes, Blinding description: This study is a double blind trial. Blinding will be done for patients. Also the researcher and the outcome assessor will be also unaware of the allocation of patients into the groups. In this study for random sequence generation, 84 eligible patients will be recruit using Permuted Block Randomization (25 blocks of size 4) through Randomization.com. in order to conceal of sequence of randomization, based on a created list, A (for intervention group) and B (for control group) letter will be written on cards and the they will put in the sequentially numbered, sealed, opaque envelopes. Then the envelopes will be numbered from 1 to 84 and will consider for eligible patients sequentially that they will be close till applying intervention. N/A Chronic Obstructive Pulmonary Disease. Intervention 1: Intervention group: The patients in intervention group will access to the Link of educational content in the developed site. The educational content consists of a lung rehabilitation program for patients with chronic obstructive pulmonary disease that will be implemented face-to-face for 2 months based on 4 steps of continuous care model including Orientation, Sensitization, Control and Evaluation. The follow up will be done weekly for 5 weeks. Intervention 2: Control group: Patients in control group will receive routine care without any intervention. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD will be shared. When: 6 months after publication the data files will be available. To whom: The data will be shared for people working in academic institutions. Conditions: Meta analyses on data is permitted. Where to obtain: Please contact to person responsible for scientific inquiries. How to obtain: The data will be available through email. Comments: Please contact to both email address: modanloo.mahnaz@goums.ac.ir modanloo.mahnaz@gmail.com
public Mahnaz Modanloo
Nursing Research Center, Golestan University of Medical Sciences, Hirkan Boulevard
Gorgan Iran (Islamic Republic of) 4917136536 +98 17 3245 6900 modanloo.mahnaz@goums.ac.ir Gorgan University of Medical Sciences scientific Shahab Eskandari nezhad
Department of Internal Medicine, Faculty of Medicine, Golestan University of Medical Sciences
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3222 0561 dr.eskandari@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Ability to write and read Ability to communicate Ability to perform the daily activities Having a smart phone Obtaining low and medium scores from the self-efficacy questionnaire 18 years no limit Both Lack of known psychiatric disorder History of participation in an educational course with the same content J44.9 CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED Behavior N/A Intervention group: The patients in intervention group will access to the Link of educational content in the developed site. The educational content consists of a lung rehabilitation program for patients with chronic obstructive pulmonary disease that will be implemented face-to-face for 2 months based on 4 steps of continuous care model including Orientation, Sensitization, Control and Evaluation. The follow up will be done weekly for 5 weeks. Control group: Patients in control group will receive routine care without any intervention. The level of Self-efficacy. Timepoint: Before intervention, immediately after intervention and one months after intervention. Method of measurement: COPD Self-Efficacy Scale. Number of rehospitalization. Timepoint: Record the number of readmissions of patients two and three months after discharge. Method of measurement: Patient clinical information registration form. Gorgan University of Medical Sciences Approved 2021-07-18 Ethics committee of Golestan University of Medical Sciences Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard Gorgan Golestan Iran (Islamic Republic of)