Designing and Evaluation of Health Promotion Program Based on a PRESID-PROCESS Model on Self-care Behaviors and Quality of Life in Hemodialysis Patients
Designing of Health Promotion Program Based on a PRESIDE-PROCESS Model on Self-care Behaviors and Quality of Life in Dialysis Patients
Design
Clinical trial, two groups, double blind
Settings and conduct
In dialysis center of Shahdad hospital in Lordegan affiliated to Shahrekord University of Medical Sciences intervention and control group were selected from the two opposite shifts. Samples were entered into study using census method and randomly divided in two groups and experimental group received training based on the information obtained from the researcher-made questionnaire. Five 40 minutes sessions were performed and questionnaires completed before, immediately and three months After intervention.
Participants/Inclusion and exclusion criteria
Entry and Exit Criteria:
Satisfaction to participate in the study
Take samples of dialysis for at least 6 months.
The sample does not suffer from mental impairment, hearing impairment, speech and mental illness, and has the ability to answer correctly the questions.
During the course of the study, you will not be able to receive education in other ways.
Dissatisfaction with the sample to continue to attend the study is a departure condition.
Intervention groups
Samples were entered into study using census method and randomly divided in two groups. 5 training sessions of 40 minutes that included awareness (2 sessions), attitude (one session), enabling factors (one session), and reinforcement factors (One session) performed for intervention group. control group received routine care, and both groups completed quality of life and self-care questionnaires before, immediately and 3 months after intervention.
Main outcome variables
Self-care behaviors, Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190301042872N1
Registration date:2019-05-25, 1398/03/04
Registration timing:retrospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Fariba Mosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5652
Email address
farebamosavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-30, 1397/07/08
Expected recruitment end date
2018-10-06, 1397/07/14
Actual recruitment start date
2018-09-30, 1397/07/08
Actual recruitment end date
2018-10-02, 1397/07/10
Trial completion date
2019-01-12, 1397/10/22
Scientific title
Designing and Evaluation of Health Promotion Program Based on a PRESID-PROCESS Model on Self-care Behaviors and Quality of Life in Hemodialysis Patients
Public title
Evaluation of PRESID-PROCESS Model on Self-care Behaviors and Quality of Life in Hemodialysis Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study.
At least 6 months before of dialysis.3.
The case study does not suffer from mental impairment and has the correct answer to the questions.
the sample has not hearing, speech, and mental impairment.
Do not receive education in other ways during the study..
Do not have kidney transplant during the study
Exclusion criteria:
Dissatisfaction with the sample to continue the study
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, sampling was done by census method, and all patients in the study participated. Then, we randomly assigned the two groups using two-way and two-point numbers in two groups of control and intervention. The pair numbers of the intervention group and the individual numbers of the control group. Depending on the dropping of the samples, 35 people will be entered in each group and will be intervened after receiving written consent and informed consent.
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 Shahrekord University of Medical Sciences
Street address
Kashani street,Nerve Center of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88961-46311
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.SKUMS.REC.1397.167
Health conditions studied
1
Description of health condition studied
patient under hemodialysis therapy
ICD-10 code
d63
ICD-10 code description
Anaemia in chronic diseases classified elsewhere
Primary outcomes
1
Description
Self-care behaviors
Timepoint
Before the intervention, immediately after the intervention, three months after the end of the intervention
Method of measurement
questionnaire
2
Description
Quality of Life
Timepoint
Before the intervention, immediately after the intervention, three months after the end of the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Self Care
Timepoint
Before the intervention and immediately after the intervention and three months after the intervention
Method of measurement
Self Care questionnaire
2
Description
Quality Of Life questionnaire
Timepoint
Before the intervention and immediately after the intervention and three months after the intervention
Method of measurement
Quality Of Life questionnaire (KQDOL)
Intervention groups
1
Description
Intervention group: In the intervention group based on the needs assessment and the questions designed in the PRECEDE-PROCESS model, the researcher will interview individually sampled interventions.Then, based on the results of the interview, the educational needs of the patient are extracted and then will be held for patients in educational sessions.
Category
Lifestyle
2
Description
Control group: Receive no specific intervention and only routine intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Fariba Mosavi
Street address
ICU Ward, Shohada hospital, Parastar Blvd, Lordegan Town
City
Lordegan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88961-46311
Phone
+98 38 3444 4444
Email
farebamosavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Professor Fatemeh Aliakbari
Street address
second floor, Research Deputy of University of Medical Sciences، Kashani Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88185-388
Phone
+98 38 1333 0061
Email
aliakbarifa@gmail.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
Fatemeh Aliakbari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani street ,Nerve Center of Shahrekord University of Medical Sciences,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88961-46311
Phone
+98 98833346691
Fax
+98 38 1333 5652
Email
aliakbarifa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fatemeh Aliakbari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani street , Nerve Center of Shahrekord University of Medical Sciences.
City
lordegan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88961-46311
Phone
+98 33346691
Fax
+98 38 1333 5652
Email
aliakbarifa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fatemeh Aliakbari
Position
Association Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani street.,Nerve Center of Shahrekord University of Medical Sciences.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88961-46311
Phone
+98 833346691
Fax
+98 38 1333 5652
Email
aliakbarifa@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data The participants in the study include demographic data and information derived from the PRECEDE-PROCEED model, and information on independent and consequential outcomes.
When the data will become available and for how long
The documentation will be published after analysis and gathering in the form of a research paper in scientific sources that will accept this documentation.
To whom data/document is available
All participants in the study, colleagues from the treatment team including physicians, nurses, paramedics and policy makers in treatment and education can benefit from this documentation.
Under which criteria data/document could be used
This documentation can be a prerequisite for the development of a study on the effects and practices of the PRECEEDE-PROCEED model on improving the health of hemodialysis patients.
From where data/document is obtainable
Contact the following email address to receive the documentation.farebamosavi@g mail.com
What processes are involved for a request to access data/document
The researcher is required to respond promptly as soon as your request is submitted through the same address