Determining the effect of the educational program based on the participatory care model on treatment adherence of patients with heart failure
Design
Clinical trial with control group, with parallel groups, double blind, randomized, phase 3 on 100 patients. Random allocation of samples to study groups is performed by block randomization method and by using R statistical software.
Settings and conduct
This double-blind randomized clinical trial study will be conducted on 100 patients with heart failure (in intervention and control group) in the heart failure clinic of Tehran Heart Center. Random allocation of samples is performing by block method and using statistical software. Random allocation of samples is performing by block method and using statistical software. The treatment adherence of patient with heart failure questionnaire will be used to collect data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age > 18 years, a diagnosis of heart failure class I to III (according to New York Heart Association Classification) approved by the fellowship, history of heart failure for at least 6 months, having at least reading and writing literacy
Non-inclusion criteria: Participation in other educational programs
Intervention groups
In intervention group, the patients with heart failure will receive an educational program based on participatory care model, including 4 sessions of participatory educational visits (weekly) and 2 sessions of continuous participatory visits (monthly) by the fellowship and nurse. Educational sessions will be held in groups with a contribution of family caregivers for 45-60 minutes. An educational booklet will be provided to patients. In control group, patients with heart failure will receive routine clinic care.
Main outcome variables
Treatment adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200910048678N3
Registration date:2022-12-25, 1401/10/04
Registration timing:prospective
Last update:2022-12-25, 1401/10/04
Update count:0
Registration date
2022-12-25, 1401/10/04
Registrant information
Name
seyede fatemeh gheiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8338
Email address
fatemeh.gheiasi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the educational program based on the participatory care model on treatment adherence of patients with heart failure
Public title
Investigating the effect of a participatory education program on treatment adherence of patients with heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 18 years
A diagnosis of heart failure class I to III (according to New York Heart Association Classification) approved by the fellowship
History of heart failure for at least 6 months
Having at least reading and writing literacy
Exclusion criteria:
Participation in other educational programs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization block method was used in this study. The size of all the blocks was equal and in this trial two groups of 4 blocks (including 2 interventions and 2 control) were formed. A random sequence was created by a statistician using R software and it was provided to the researcher and based on the code assigned to each group (A, B), people were divided into two groups without researcher's interference.
Blinding (investigator's opinion)
Double blinded
Blinding description
The random allocation of samples in two groups was done by the collaborator of the project who had no conflict of interest. The samples were marked with code A and B, and the outcome evaluator and statistician did not know about it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences
Street address
East Nusrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
141973317
Approval date
2020-02-12, 1398/11/23
Ethics committee reference number
IR.TUMS.FNM.REC.1398.174
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Mean score of treatment adherence
Timepoint
Before and after the intervention
Method of measurement
Treatment adherence of patient with heart failure questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients with heart failure will receive an educational program based on participatory care model, including 4 sessions of participatory educational visits (weekly) and 2 sessions of continuous participatory visits (monthly) by the fellowship and nurse. Educational sessions will be held in groups with a contribution of family caregivers for 45-60 minutes. An educational booklet will be provided to patients.
Category
Lifestyle
2
Description
Control group:Patients with heart failure will receive routine clinic care.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart failure clinic, Tehran heart center
Full name of responsible person
Seyede Fatemeh Gheiasi
Street address
North Kargar, corner of Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
fatemeh.gheiasi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Nikbakht Nasrabadi
Street address
East Nosrat st. Tohid sq.
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
nursing_intl@tums.ac.ir
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
Seyede Fatemeh Gheiasi
Position
PhD Candidate in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
East Nusrat st. Tohid sq.
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4412
Email
fatemeh.gheiasi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Navab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
East Nusrat st. Tohid sq.
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4412
Email
elhamnavab2@gmail.com
Web page address
https://old.tums.ac.ir/faculties/e-navab
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyede Fatemeh Gheiasi
Position
PhD Candidate in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
East Nosrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4412
Email
fatemeh.gheiasi@gmail.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
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available