The main goals of the project:
Determining the effect of self-management program on anxiety and depression in people with chronic obstructive pulmonary disease
objectives of the project:
- Comparison of anxiety in control and intervention groups before the intervention
- Comparison of depression in control and intervention groups before the intervention
- Comparison of anxiety of control and intervention groups three months after the intervention
- Comparison of depression of control and intervention groups three months after the intervention
Design
The present study is a double-blind randomized clinical trial study.
Settings and conduct
Participants will be selected from the hospitals of Hazrat Rasool Akram (PBUH) of Iran University of Medical Sciences and Imam Khomeini Hospital of Tehran University of Medical Sciences. Then, the questionnaires will be completed by the patients. Data collection tools include a demographic information questionnaire and a hospital anxiety and depression questionnaire. The researcher will then teach self-management skills to intervention group members. Three months after the intervention, the questionnaires will be completed again by the members of the control and testing group to examine the impact of the interventions in both groups.
Participants/Inclusion and exclusion criteria
Entry : Having chronic obstructive pulmonary disease
Not Entry : having a life-threatening illness
Intervention groups
The researcher will educate the self-management skills to intervention group members, and control group members will receive only common training in the department. In the intervention group, face-to-face training will be given to individuals. Educational aids such as displaying images and videos on a laptop or mobile phone and various forms of pills and inhalers will also be used for training.
Main outcome variables
Depression and Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160704028781N4
Registration date:2020-05-14, 1399/02/25
Registration timing:registered_while_recruiting
Last update:2020-05-14, 1399/02/25
Update count:1
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
Farshad Heidari Beni
Name of organization / entity
Iran Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 38 3372 3354
Email address
heydari-bani.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-07-10, 1399/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management program on anxiety and depression of people with chronic obstructive pulmonary disease
Public title
The effect of self-management on anxiety and depression of people with chronic obstructive pulmonary disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the disease by the specialist physician
having the ability to understand and speak and read and write in Persian
having the physical ability to interview and complete the questionnaire
not participating in previous self-management programs for chronic obstructive pulmonary disease
lack of hearing problems and problems Disruption of communication
non-use of anti-anxiety or anti-depressant drugs
45 to 70 years age
Exclusion criteria:
Having a life-threatening illness
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in groups will be by random blocks without being replaced in each center. For this purpose, first the letter A for the control group and the letter B for the intervention group are considered and different modes of the two groups are written on the cards and each of them is placed in a closed and opaque envelope. These envelopes are placed in a box and before selecting the card, the researcher does not know the participants will be palace in what group. The statistician (unaware of the study and the groups) with picking up one of the envelopes from the box, will determines the patients entering the study will be in which group, respectively. This process is continued until all the cards are taken out of the box and the cards are returned to the box again and this random selection is repeated to provide the desired sample size. To cover the random allocation, the blocks with different numbers will be used, ie six blocks and two blocks will be entered into the blocks. The six blocks can be a combination of ABBABA and so on. Double blocks can also include AB, BA.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome evaluators and data analysts are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Approval date
2019-12-05, 1398/09/14
Ethics committee reference number
IR.TUMS.FNM.REC.1398.155
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
The level of depression
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Hospital Anxiety and Depression Questionnaire (HADS)
2
Description
The level of anxiety
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Hospital Anxiety and Depression Questionnaire (HADS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The researcher will educates the self-management skills to the intervention group members. In this group, the education will be given face-to-face. Educational aids such as displaying images and videos on a laptop or mobile phone and various forms of pills and inhalers will also be used for training. Educational content includes self-management training for chronic obstructive pulmonary disease, which includes introducing the patient, introducing and expressing the importance of self-management, drug information required in this disease, prevention and management of relapses, exercise and physical activity in the disease, reduction methods. Shortness of breath, energy-saving techniques, airway cleansing techniques, and proper nutrition in chronic obstructive pulmonary disease. The content of the training program will be guided by the guidelines for patients with chronic lung obstruction written by the Australian Lung Association, which has been approved by faculty members of the Department of Surgery, School of Nursing and Midwifery, Iran. The number of education sessions will include four two-hour sessions on consecutive days. After the first session in each session, first, the contents of the previous session will be reviewed for 30 minutes and answer the patients' questions, and then new content will be presented. Intervention group members will be contacted every two weeks to ensure that they perform the self-management interventions correctly.
Category
Rehabilitation
2
Description
Control group: They will only receive routine care and will not receive any additional education.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital (PBUH) of Iran University of Medical Sciences and Imam Khomeini Hospita
Full name of responsible person
Farshad Heidari-Beni
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
Heidarifarshad70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Nahid Dehghan Nayeri
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
nahid.nayeri@gmail.com
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
Farshad Heidari-Beni
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
Heidarifarshad70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Nahid Dehghan Nayeri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
nahid.nayeri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farshad Heidari Beni
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
Heidarifarshad70@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Is confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available