The effect of Tele-Nursing on blood pressure control and Self-care behaviors in patients with chronic hypertension referred to comprehensive urban and rural health service centers in Garmeh- in 2020.
The effect of tele-nursing on blood pressure control and self-care behaviors in patients with chronic hypertension
Design
The present study is a randomized control trial which allocate in control and intervention group. The intervention group will receive the supplementary education on self-care behaviors and blood pressure control within 3 months, while the control group will receive only routine care and training.
Settings and conduct
Cluster sampling will be done in the comprehensive urban and rural health service centers of Garmeh province.
Participants/Inclusion and exclusion criteria
subjects are consist of patients suffer from chronic hypertension who have following criteria: Inclusion Criteria : 1- Being between 30 to 75 years old 2- Being native 3- Access to telephone 4- Confirmed hypertension by a family doctor and having a registered file in the Comprehensive Health Service Center 5- At least 6 months of history of hypertension 6- Taking at least one anti hypertensive drug by the patient 7- Not going under dialysis 8- Not suffering from debilitating disease 9- No cognitive impairment 10- No substance abuse 11- Ability to communicate in Persian 12- Having literacy to read and write Completion of the questionnaire 13- Willingness to participate in the study Exclusion Criteria are include of: 1- suffering from speech and hearing impairment 2- Participating in a similar training course during the last 6 months
Intervention groups
In the intervention group, patients will be given the essential training on self-care behaviors and blood pressure control through tele-nursing technique during 3 months, while the control group will receive standard treatment.
Main outcome variables
Promoting self-care behaviors and blood pressure control behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201105049279N1
Registration date:2020-12-25, 1399/10/05
Registration timing:registered_while_recruiting
Last update:2020-12-25, 1399/10/05
Update count:0
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
Fatemeh Talebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3250 3545
Email address
talebif97@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tele-Nursing on blood pressure control and Self-care behaviors in patients with chronic hypertension referred to comprehensive urban and rural health service centers in Garmeh- in 2020.
Public title
Effect of Tele- Nursing on blood pressure control and Self-care behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 30 and 75 years old
Indigenous (resident of Garmeh city)
Phone access
Confirmation of high blood pressure by a family doctor and having a file in the Comprehensive Health Service Center
At least 6 months of history of hypertension (duration of the disease is more than 6 months)
Taking at least one anti hypertensive drug by the patient
Do not have dialysis patients
No debilitating disease
Lack of cognitive impairment
No substance abuse
Ability to speak and understand Persian by the patient and her companion
Have reading and writing literacy to complete the questionnaire
Willingness and satisfaction to participate in the study
Exclusion criteria:
Having speech and hearing impairments
Participating in a similar training course during the last 6 months
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
First, by coin tossing randomly select 5 centers by cluster approach among 10 comprehensive urban health service centers (6 centers) and rural (4 centers). In this way, among the 5 clusters, the samples are randomly divided into two group of control and intervention based on permuted random blocks sampling (urban and rural). That is, we can randomly select samples by making 20 *4 blocks. In this part, we can also choose the two groups of control and intervention by dropping coins.
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 Sabzevar University of Medical Sciences
Street address
Sabzevar, Nuclear Martyrs Boulevard, Above the Unknown Martyrs, Campus of the University of Medical Sciences, Office of the Vice President for Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114 - 9617913
Approval date
2020-12-20, 1399/09/30
Ethics committee reference number
IR.MEDSAB.REC.1399.127
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
Blood pressure control
Timepoint
pre and post intervention
Method of measurement
Use of self-care questionnaire and Abbreviated Mental Test(AMTs)
2
Description
self-care behaviors
Timepoint
pre and post intervention
Method of measurement
Self-care behavior control
Secondary outcomes
1
Description
Blood pressure control
Timepoint
Pre and post intervention
Method of measurement
By sphygmomanometer
Intervention groups
1
Description
Intervention group: in the intervention group, in addition to the virtual training session that is held for all research samples, remote nursing (counseling and telephone follow-up) will be performed by researchers for 3 months. In this way, telephone calls are made to follow up blood pressure control and self-care behaviors twice a week in the first month and once a week during the second and third months, with members of the intervention group.The duration of the conversation will be estimated at an average of 15 minutes and the researcher will be able to contact patients during office hours. The content of the conversations included introducing themselves, asking about the general health status of the participants, encouraging them to follow the recommendations and aspects of public and private care, following up on training needs based on their training needs, providing suggested solutions and answering questions. They will be. Phone calls and their content will be recorded for each participant in specific tabs to be re-evaluated in subsequent calls.
Category
Other
2
Description
Control group: During the intervention, the control group will receive standard treatment. This treatment includes medication and training on how to take medication and adhere to a changing diet, lifestyle and physical activity.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban and rural health service centers of Garmeh city
Full name of responsible person
Fatemeh Talebi
Street address
parastar Street - between parastar 3 and 5
City
Garmeh
Province
North Khorasan
Postal code
9431644166
Phone
+98 58 3250 3545
Email
Amir.talebi325035@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology of Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Qorat
Street address
Nurse Street - between Nurse 3 and 5
City
Garmeh
Province
North Khorasan
Postal code
9431644166
Phone
+98 58 3250 3545
Email
Amir.talebi325035@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology of Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Talebi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nurse Street - between Nurse 3 and 5
City
Garmeh
Province
North Khorasan
Postal code
9431644166
Phone
+98 58 3250 3545
Email
Amir.talebi325035@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Talebi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nurse Street - between Nurse 3 and 5
City
Garmeh
Province
North Khorasan
Postal code
9431644166
Phone
+98 58 3250 3545
Email
Amir.talebi325035@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Talebi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nurse Street - between Nurse 3 and 5
City
Garmeh
Province
North Khorasan
Postal code
9431644166
Phone
+98 58 3250 3545
Email
Amir.talebi325035@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