Investigating the effect of multidisciplinary support package on burden and patient interaction with family caregivers of patients with chronic obstructive pulmonary disease(COPD).
Determining the effect of multidisciplinary support package on burden and patient interaction with family caregivers of patients with chronic obstructive pulmonary disease(COPD).
Design
A randomized controlled trial clinical trial with parallel, single blinded groups. Phase 2-3.
Settings and conduct
Caregivers bear a high burden for patients with COPD. Therefore, interventions to reduce the burden appear to be necessary.The research will be conducted in Birjand Pulmonary Disease Clinic in three phases. In the first phase training sessions will be held by specialists. In the second phase will be conducted by a psychiatric nurse. The data analyzer will not know the intervention type.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Ability to read and write, Caregivers of patients with severe or very severe chronic obstructive pulmonary disease according to a lung specialist, Physical ability in patient care, Absence of other life-threatening diseases in the patient except COPD.
Exclusion criteria:Absent caregiver in more than two sessions of intervention, patient death during the intervention, Affecting a COPD caregiver with a debilitating diseases.
Intervention groups
Intervention group:The support package will be offered in three main phases.
In the first phase, 3 training sessions will be held by the lung disease specialist and the COPD specialist nurse. Each session will be 60 minutes.At the end of each session, the content will be delivered as a pamphlet to caregivers.In Phase II, two 60-minute training sessions will be conducted by an experienced Psychiatric nurse.n the third phase, peer support and training sessions will be held in 3 sessions.
Control group:Caregivers in the control group will receive the routine services provided by the health centers.
Main outcome variables
Burden of care;Caregiver-patient communications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190515043601N4
Registration date:2020-03-29, 1399/01/10
Registration timing:registered_while_recruiting
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Hossein Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1427
Email address
hosseinrahimi92@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of multidisciplinary support package on burden and patient interaction with family caregivers of patients with chronic obstructive pulmonary disease(COPD).
Public title
Investigating the effect of multidisciplinary support package on burden and patient interaction with family caregivers of patients with chronic obstructive pulmonary disease(COPD).
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write.
Caregivers of patients with severe or very severe chronic obstructive pulmonary disease, according to a lung specialist
Physical ability in patient care
Absence of other life-threatening diseases in the patient except COPD
Ages 18 to 60 yearsold
Exclusion criteria:
Absent caregiver in more than two sessions of intervention
Patient death at time of intervention
Affecting a COPD caregiver with a debilitating diseases.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were divided into control and intervention groups using blocking method.The blocks size will be 4.The random split action will proceed until the second participant is randomly assigned to a group.Afterwards, participants will be automatically assigned to another group, Until block 4 is completed. This process will continue evenly until the groups are completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will be unaware of the type of intervention for each group.Pre-intervention questionnaires will be coded in the intervention group with the letter M and the control group with N. Questionnaires will be coded after intervention in intervention group with letter G and control group with H.The coding will be done by the researcher.No one other than the researcher will know about coding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Birjand University of Medical Sciences
Street address
Ayatollah Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.BUMS.REC.1397.360
Health conditions studied
1
Description of health condition studied
Burden of care
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Patient-Caregiver communication
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Relationship scores from the Dyadic Relationship Scale(DRS)
Timepoint
Before, immediately and two months after the end of the intervention
Method of measurement
Dyadic Relationship Scale
2
Description
Burden of care scores from the Zarit Burden Interview(ZBI)
Timepoint
Before, immediately and two months after the end of the intervention
Method of measurement
Zarit Burden Interview(ZBI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In the first phase, 3 training sessions will be held by the lung disease specialist and the COPD specialist nurse. Each session will be 60 minutes.At the end of each session, the content will be delivered as a pamphlet to caregivers.In Phase II, two 60-minute training sessions will be conducted by an experienced Psychiatric nurse.n the third phase, peer support and training sessions will be held in 3 sessions.
Category
Other
2
Description
Control group: Caregivers in the control group will receive the routine services provided by the health centers.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Alireza Mahmoudirad
Street address
Ayatollah Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3204 1088
Email
dr_mahmoodi_rad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tuba Kazemi
Street address
ghafari
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Faculty member of Birjand university of medical science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor,Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1427
Fax
Email
Hosseinrahimi92@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Faculty member of Birjand university of medical science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable participants
When the data will become available and for how long
Start of access period 12 months after publishing results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to access the data, researchers can request access to the information 12 months after the results are published. Within two weeks, the information will be sent to them.It should be noted that applicants must be faculty members of the Ministry of Health.
From where data/document is obtainable
Applicants can apply to the Birjand University of Medical Sciences School of Nursing and Midwifery for information.
What processes are involved for a request to access data/document
After verifying the identity of the applicant, the data will be submitted to the researcher within 2 weeks.