Determining the effect of empowerment and telephone follow-up on the quality of life and readmission of patients with high blood pressure
Design
Using a random block of 4, the patients are assigned to two test groups (A) and control (B). In this way, first, all the possible combinations of the two groups A and B are written in blocks of 4, and 6 blocks are obtained. will come, then with 20 random selections from 6 possible blocks, the process of entering and assigning patients to two groups was determined in advance. The control group (n=40) and the intervention group (n=40) were.
Settings and conduct
Holding empowerment classes for high blood pressure patients in Social Security and Shafa hospitals in Takestan city on a weekly basis for 2 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with a history of high blood pressure and receiving at least one anti-hypertensive drug for the previous year
2. Age between 30-75 years
3. The ability to understand and communicate with the patient or his caregiver in Farsi
4. No history of diet therapy
5. Willingness to participate in the study
6. Lack of experience of the presence of the patient or his companion in blood pressure management classes
7- Patient/caregiver access to landline or cell phone
Exit criteria:
1. Mental disorders for unknown reasons
2. Addiction to drugs or psychotropic drugs
3. History of heart surgery in the last 6 months
4. Absence more than once in training sessions
5. Extreme stress while studying
6. Death of the patient
Intervention groups
The group that received empowerment training classes in the field of blood pressure
Main outcome variables
Quality of life and readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240516061813N1
Registration date:2024-06-20, 1403/03/31
Registration timing:prospective
Last update:2024-06-20, 1403/03/31
Update count:0
Registration date
2024-06-20, 1403/03/31
Registrant information
Name
saeide doost mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3523 9125
Email address
saeedeh.dm6475@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empowerment and telephone follow-up on the quality of life and readmission of patients with high blood pressure
Public title
Investigating the effect of empowerment and telephone follow-up on the quality of life and readmission of patients with high blood pressure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of high blood pressure and receiving at least one antihypertensive drug for the previous year
Age between 30-75 years
The ability to understand and communicate with the patient or her caregiver in Farsi
No history of diet therapy
Willingness to participate in the study
Lack of experience of the presence of the patient or her companion in blood pressure management classes
Patient/caregiver access to a landline or cell phone
Exclusion criteria:
Age
From 30 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
40
40 people in the test group and 40 people in the control group
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two test groups (A) and control (B) using the random block method of 4. Thus, first, all the possible combinations of the two groups A and B are written in blocks of 4, which will result in 6 blocks. Then, with 20 random selections from 6 possible blocks, the process of entering and assigning patients to two groups is determined in advance. Therefore, without any bias, the patients will be divided into two groups of 40 people, test and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
The people who will examine the desired outcome, including readmission and quality of life, do not know about the control and intervention groups, and the researcher analyzing the data also does not know about the people in the control and intervention groups.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
nrec ethics committee for research project
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
takestan
Province
Qazvin
Postal code
59811-34197
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.QUMS.1403.011
Health conditions studied
1
Description of health condition studied
hypertention
ICD-10 code
I10-I15
ICD-10 code description
Hypertensive diseases
Primary outcomes
1
Description
readmission
Timepoint
After one Month
Method of measurement
Hospitalization statistics of patientsThe statistics of rehospitalization of patients after one month from the time of discharge
2
Description
Quality of Life
Timepoint
After one MonthDischarge time and one month after discharge
Method of measurement
Through the SF-36 quality of life questionnaire
Secondary outcomes
1
Description
hypertention
Timepoint
Time of discharge-completion of the study
Method of measurement
Barometer
Intervention groups
1
Description
Intervention group: For patients with high blood pressure, the training class is conducted in 6 sessions weekly at 10-12 in the morning. After the last training session every week for one month, all patients were followed up by phone, quality of life questionnaire, demographic information and monitoring. The blood pressure of the patients is completed once upon discharge from the ward and again after the completion of the intervention.
Category
Lifestyle
2
Description
Control group: In the control group, only routine trainings are provided and follow-up after discharge by the health promotion unit of the hospitals. After the last training session, every week for one month, all the control and intervention patients were followed up by phone. The quality of life questionnaire, demographic information and blood pressure monitoring of the patients of both groups were completed once upon discharge from the ward and once again after the completion of the intervention. Re-hospitalization of patients in both groups is also evaluated during phone calls.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
shafa Hospital, Social Security Hospital Takestan
Full name of responsible person
saeide doust mohammadi
Street address
Qazvin, Takestan, Fakuri Street, Shafa Hospital
City
takestan
Province
Qazvin
Postal code
3481343961
Phone
+98 28 3524 9211
Email
saeedeh.dm6475@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
leili yekefallah
Street address
Shahid Bahonar St., Qazvin University of Medical Sciences
City
takestan
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
leili_fallah@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
50
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
Qazvin University of Medical Sciences
Full name of responsible person
saeide doost mohammadi
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Modares St., 12 Tehseh Alley, Plak 21
City
takestan
Province
Qazvin
Postal code
3481343961
Phone
+98 28 3524 9211
Email
saeedeh.dm6475@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
leili yekfallah
Position
nurse
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
takestan
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
leili_fallah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
saeide doost mohammadi
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
takestan
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
saeedeh.dm6475@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to patients' lack of consent to share information