Studying the effect of family-based empowerment model on self-efficacy and quality of life in hypertensive patients visiting comprehensive health centers
Determining the effect of family-based empowerment model on self-efficacy and quality of life in hypertensive patients visiting comprehensive health centers
Design
Two arm parallel group randomized trial, not blinded, randomized by drawing, done on 70 patients.
Settings and conduct
The study site was Hijrat and Musa Ibn Jafar Health Center in Zahedan. No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hypertension was diagnosed at least 6 months ago; having the ability to read and write; being at the age of 25-65 years old.
Non-inclusion criteria: Has not participated in a training program during the last 6 months.
Intervention groups
Intervention group: Family-centered empowerment based on steps in 4 sessions of 60 minutes for 4 weeks individually, with the participation of the patient and a family member, in a suitable place for training in comprehensive health centers of Zahedan and preferably during office hours using PowerPoint, educational video and the tutorial will be done. Control group: the control group will not receive any training.
Main outcome variables
Quality of life; self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201016049043N1
Registration date:2020-11-21, 1399/09/01
Registration timing:registered_while_recruiting
Last update:2020-11-21, 1399/09/01
Update count:0
Registration date
2020-11-21, 1399/09/01
Registrant information
Name
Mahsa Asadollahi hamedani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 4594
Email address
mahsaa.asadollahi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of family-based empowerment model on self-efficacy and quality of life in hypertensive patients visiting comprehensive health centers
Public title
The effect of family-based empowerment model in hypertensive patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed high blood pressure from at least 6 months ago
Caregiver has at least reading and writing literacy
Being at the age of 25-65 years old
Exclusion criteria:
Participating in a training program similar to the current training program during the last 6 months
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done in several stages. First, urban areas are considered as clusters, then two areas are randomly selected, and then from each area, a center is identified by drawing a number, and the centers are allocated to intervention or control by drawing a number. Samples from selected centers will then be selected simply and consecutively and based on inclusion criteria.
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 Zahedan University of Medical Sciences
Street address
Medical Sciences Campus, Dr. Hesabi square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-08-10, 1399/05/20
Ethics committee reference number
IR.ZAUMS.REC.1399.171
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Self-efficacy score in the specific self-efficacy questionnaire of hypertensive patients
Timepoint
At the beginning of the study (before the intervention) and 1 month and 3 months after the intervention
Method of measurement
Specific self-efficacy of hypertensive patients questionnaire
2
Description
Quality of life score in the quality of life questionnaire specific to hypertensive patients.
Timepoint
Measurement of quality of life at the beginning of the study (before the intervention) and 1 month and 3 months after the intervention.
Method of measurement
Quality of life questionnaire specific to hypertensive patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Family-centered empowerment based on steps or pattern according to the training program designed for each group in 4 60-minute sessions for 4 weeks individually, with the active participation of the patient and a family member (at least the main caregiver of the family) in the form of discussion and questions and answers will be done by the researcher in a suitable place for training in comprehensive health centers and preferably during office hours using teaching aids such as PowerPoint, educational videos and educational booklets and the control group will not receive any training. Step 1 (Understanding the threat): The first step in the family-centered empowerment model is to increase the intensity and sensitivity perceived in order to sensitize and raise the level of information of patients and their families through lectures and discussions about the nature and complications of the disease, aggravating factors Disease, nutritional factors, exercise and effective factors in disease control will be implemented. At the end of the training session, questions and answers will be done to ensure the understanding of the content. Step 2 (Self-Efficacy): At this stage, problem solving or problem solving will be implemented. For this purpose, problem solving sessions (two 60-minute sessions) will be held individually for patients and their families. In these sessions, patients and families will be confronted with problems and the problem-solving process, and will be asked to discuss concrete examples of their situation and what they have done to improve the problem. Also in this session, practical methods of measuring weight and blood pressure (in detail) and the consequences of not controlling these two variables and its normal amount will be explained. Patients and families will then be asked to practice this skill. At this stage, the best way to solve patients' problems will be selected and the client's skills will be emphasized. Step 3 (self-confidence and increase self-confidence): At this stage, the patient will be asked to teach the family the issues raised in the previous sessions during the session with the help of the researcher, and if help and guidance is needed, the researcher will do this. The purpose of this step is to increase patients' self-confidence due to their ability to provide information to family members and family support. To ensure and follow up on this step, a number of questions related to the training issues will be given to the patient to complete with family members and submit to the researcher (one week). Step 4 (Evaluation): Process evaluation during the process Intervention in all sessions will be done with questions and answers about the items mentioned in the previous sessions. The final evaluation will be done one and three months after the intervention in the two groups by completing the questionnaires of quality of life and self-efficacy. Also, during the research, the researcher will be in contact with the research units by phone in order to solve possible problems and questions.
Category
N/A
2
Description
Control group: Get routine care.In terms of observing ethical issues at the end of the intervention, an educational booklet based on valid scientific texts will be prepared under the supervision of experts in this field and will be provided to participants in both intervention and control groups.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hijrat Health Center
Full name of responsible person
Mrs Fatemeh Ardalan
Street address
Daneshgah 31, Daneshgah boulevard, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9179964143
Phone
+98 54 3344 0059
Email
MAHSAA.ASADOLLAHI@GMAIL.COM
2
Recruitment center
Name of recruitment center
Musa Ibn Ja'far Health Center
Full name of responsible person
Mrs Zahra Mir
Street address
In front of Mostafa Khomeini 27, Mostafa Khomeini street, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9179964143
Phone
+98 54 3344 4886
Email
mahsaa.asadollahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Medical Sciences Campus; Dr. Hesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2116
Email
mahsaa.asadollahi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr Alireza Salar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mashahir square; Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
salar293@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Alireza Salar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mashahir square; Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344242
Email
salar293@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
mahsa asadollahi hamedani
Position
researcher-student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mashahir square; Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
8169133969
Phone
+98 54 3344 2482
Email
mahsaa.asadollahi@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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals. Questionnaires containing information of patients in this study, including age, sex and any other information that is collected and analyzed are available.
When the data will become available and for how long
Access 5 months after the end of the intervention
To whom data/document is available
Researchers working in academic and scientific institutionوابسته به سازمان معتبر باشدs
Under which criteria data/document could be used
Be affiliated with a reputable organization
From where data/document is obtainable
email: mahsaa.asadollahi@gmail.com
What processes are involved for a request to access data/document
Send message via email and receive a reply within 7 working days