The effect of family-centered empowerment model on self-efficacy, quality of sleep and the level of the fatigue in patients with chronic obstructive pulmonary disease
The effect of family-centered empowerment model on self-efficacy and sleep quality of people with chronic obstructive pulmonary disease
Design
A clinical trial with a control group
Settings and conduct
Hospitals affiliated to Shahrekord University of Medical Sciences
implementation:
Firstly, demographic, sleep quality, self-efficacy, and fatigue questionnaire completed by the researcher, then educational intervention based on the family-centered empowerment model in four-session 90-minute on four steps of perceived threat, problem-solving, educational participation, and evaluation in groups of 10 to 15 with the presence of family members or at least the primary caregiver of the family will be performed, the final evaluation will be done three months after the intervention and at this stage again the questionnaires will be completed by the researcher and according to the patients' statements in both intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Chronic obstructive pulmonary disease diagnosed by a physician.
2- Admitted to an internal ward of hospitals affiliated to Shahrekord University of Medical Sciences.
3. Under 70 years
4. Mental health
5-Ability to attend training sessions.
6. FEV1 above 35%
7. Has no other underlying disease
8. At least be literate
. Exclusion criteria:
1. Inappropriate physical condition
Intervention groups
intervention group :
Patients with chronic obstructive pulmonary disease who were selected based on inclusion criteria and then under educational and supportive interventions based on a family empowerment model.
control group :
Patients with chronic obstructive pulmonary disease who selected base on inclusion criteria and receive treatment and care available in the ward.
Main outcome variables
Self-efficacy, quality of sleep and level of fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190303042900N3
Registration date:2019-12-04, 1398/09/13
Registration timing:retrospective
Last update:2019-12-04, 1398/09/13
Update count:0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Shahriyar Salehitali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 9321
Email address
sh.salehitali@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on self-efficacy, quality of sleep and the level of the fatigue in patients with chronic obstructive pulmonary disease
Public title
The effect of family-centered empowerment model in patients with chronic obstructive pulmonary disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of chronic obstructive pulmonary disease by a physician.
Admitted to an internal ward of hospitals affiliated to Shahrekord University of Medical Sciences.
Under 70 years
Mental health
Ability to attend training sessions.
FEV1 above 35%
Has no other underlying disease
At least be literate
Exclusion criteria:
Inappropriate physical condition
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples who have study criteria were selected by as easy sampling. Then the samples were randomly divided into intervention and control groups. As 40 cards in red and 40 cards in blue were placed in a pot then the study population were asked to remove one card from the pot. Those who took out the red card were included in the intervention group, and those who took out the blue card were in the control group. The process continued to remove all 80 cards to complete the sample size of participants study.
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
Ethics Committee Of Shahrkord University Of Medical Sciences
Street address
University Of Medical Sciences, Rahmatie, Shahrkord Town
The beginning of the study and after the intervention
Method of measurement
Standardized self-efficacy questionnaire in COPD patients
2
Description
sleep quality
Timepoint
The beginning of the study and after the intervention
Method of measurement
Pittsburgh sleep quality index questionnaire
3
Description
Fatigue
Timepoint
The beginning of the study and after the intervention
Method of measurement
The Krupp (FSS) Fatigue Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Educational and supportive interventions based on the family-centered empowerment model in four 90-minute sessions in groups of 10 to 15 with family members based on a four-step family-centered empowerment model that includes perceived threat, problem-solving, Educational participation and evaluation are provided
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Shahriyar Salehi tali
Street address
ayatollah kashani hospital, nurse ave
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4826
Email
Kashani@skums.ac.ir
2
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Shahriyar Salehi tali
Street address
Hajar hospital, nurse ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3222 0016
Email
hajar@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrkord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Kamal_Solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahriyar Salehi Tali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences,Rahmatie,Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
sh.salehitali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahriyar Salehi Tali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences,Rahmatie,Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
sh.salehitali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahriyar Salehi Tali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
sh.salehitali@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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