Protocol summary
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Study aim
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Determining the effect of implementing family-centered empowerment program on the recovery process and treatment compliance of patients after coronary angioplasty.
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Design
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The clinical trial with control group, with parallel groups, without blinding.
The samples will be allocated in two intervention and control groups by random block allocation method with 4 blocks of equal size and a combination of letters A for the intervention group and B for the control group.
The sample size will be 84 people based on the estimate of the statistical consultant and taking into account the possibility of dropping out.
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Settings and conduct
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Location: Selected hospitals of Tehran University of Medical Sciences
During 8 sessions, there will be 5 training sessions and 3 follow-up sessions and 1 session every week. Group meetings will be held in groups of 4 to 7 people for 20-30 minutes.
Completing the questionnaires again immediately after the intervention and also 4 weeks after the completion of the interventions
Providing training booklets to both groups.
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Participants/Inclusion and exclusion criteria
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The study inclusion criteria include:
Adults from18 to 60 years old
Diagnosis of coronary artery disease by a specialist doctor
Presence of patients on the waiting list for coronary angioplasty
The cooperation of one family member with the patient
Having minimum reading and writing literacy for the patient and active family member
Non-entry criteria:
The existence of diagnosed psychological problems
Participate in similar empowerment program
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Intervention groups
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In this 8-week study, the control group will receive the usual care, while the intervention group will also receive the comprehensive heart empowerment program in addition to the usual care. booklet will be available to the control group in order to comply with ethical considerations.
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Main outcome variables
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Adherence to Treatment
Recovery process
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220929056055N1
Registration date:
2023-04-24, 1402/02/04
Registration timing:
registered_while_recruiting
Last update:
2024-01-08, 1402/10/18
Update count:
1
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Registration date
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2023-04-24, 1402/02/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-03-11, 1401/12/20
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Expected recruitment end date
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2023-06-12, 1402/03/22
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of comprehensive family-centered empowerment program on Adherence to Treatment and recovery process in patients after coronary angioplasty
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Public title
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The effect of comprehensive family-centered empowerment program on Adherence to Treatment and recovery process in patients after coronary angioplasty
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Adults from 18 to 60 years old
Diagnosis of coronary artery disease by a specialist doctor
Presence of patients on the waiting list for coronary angioplasty
The cooperation of one family member with the patient
Having minimum reading and writing literacy for the patient and active family member
Exclusion criteria:
Psychological problems has been diagnosed
Failure to participate in a similar empowerment program
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The samples will be selected through continuous sampling and will be divided into two intervention and control groups. The sample members will be allocated in two intervention and control groups by random block allocation method with 4 blocks of equal size and a combination of letters A for the intervention group and B for the control group. Then, the cards containing the blocks are placed inside the standard envelope, and based on the eligible inpatient samples, an envelope will be selected by the researcher by random sampling method, and finally, the method of random allocation of research samples will be determined.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-09-28, 1401/07/06
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Ethics committee reference number
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IR.TUMS.FNM.REC.1401.076
Health conditions studied
1
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Description of health condition studied
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Coronary Artery Disease
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ICD-10 code
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I70-I79
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ICD-10 code description
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کد ذیل مربوط به بیماری های شریانی است.
Primary outcomes
1
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Description
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The rate of patient recovery with the recovery process questionnaire
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Timepoint
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Before and after the intervention and 4 weeks after the end of the intervention
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Method of measurement
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Questionnaire of recovery process
Secondary outcomes
1
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Description
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The degree of compliance with the treatment plan in the questionnaire of adherence to treatment regimen
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Timepoint
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Before and after the intervention and 4 weeks after the end of the intervention
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Method of measurement
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Questionnaire of adherence to treatment regimen
Intervention groups
1
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Description
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Intervention group: 8 family-centered intervention sessions will be conducted in the form of 5 group training sessions and 3 follow-up sessions and 1 session every week. Group meetings will be held in groups of 4 to 7 people for 20-30 minutes. During these sessions, he will provide training on the nature of the disease, factors affecting the aggravation or improvement of symptoms, methods of preventing heart diseases by modifying lifestyle, physical activity, proper nutrition, stress control methods, follow-up of drug therapy and adherence to the treatment plan. became. Then, the researcher will encourage the members of the intervention group to have a group discussion and exchange their experiences related to the disease and the complications they experienced and lifestyle. Also, the training booklet will be given to the sample members to read it and ask the researcher any questions that come to their mind. The family members attend the meetings and in these meetings under the supervision of the researcher, they will discuss their problems and how to solve them, which will finally end in adopting a solution and try to strengthen the patients' ability in this field. In the step of educational participation, the family members are asked to transfer the learned information to the patient in the presence of the researcher along with the educational card. The last meeting will be held with the presence of an active member of the family to review the received training and fix the problems and summarize the meetings and evaluate the model. Evaluation is done in two ways: Formative and Summative evaluation. Formative evaluation will be in the form of questions and answers during each session will be from the topics of the previous sessions, and the Summative evaluation will be for the completion of the questionnaires immediately after the intervention and the re-completion of the questionnaires will be done 4 weeks after the completion of the interventions. In order to comply with ethical considerations, the training booklet was also provided to the control group.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available