Assessing the effectiveness of community-based intervention through planned approach to community health(PATCH) on disease perception, empowerment and self-care behaviors of patients with hypertension
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
2024-01-05, 1402/10/15
2024-05-21, 1403/03/01
2024-0105-0521 00:00:00
2024-02-04, 1402/11/15
2024-06-21, 1403/04/01
2024-0206-0421 00:00:00
empty
The recruitment date of the participants has changed.
The recruitment date of the participants has changed.
empty
تاریخ تخصیص شرکت کنندگان در مطالعه تغییر کرده است.
تاریخ تخصیص شرکت کنندگان در مطالعه تغییر کرده است.
Protocol summary
Study aim
Determining the effectiveness of community-based intervention with a planned approach to community health in the perception of the disease, improving the ability and self-care behaviors of patients with hypertension
Design
The sampling method in this study will be cluster random. 12 comprehensive rural health service centers and one health house from each center is randomly selected. By applying the block random allocation protocol with 4 blocks, six health houses are assigned to the intervention group and six health houses to the control group. The required number of samples will be extracted by simple random from the list of patients with high blood pressure. A total of 428 people is considered as the sample size.
Settings and conduct
Sampling will be cluster random. The location of the study is the villages of Babol city.
Participants/Inclusion and exclusion criteria
People whose blood pressure is equal to or higher than 140/90, who are literate, who are covered by comprehensive rural health service centers of Babol, can enter the study. The criteria for withdrawing from the study are people's dissatisfaction with continuing to participate in the study, migration or death.
Intervention groups
he research population includes people with high blood pressure. In this study, a planned approach to community health will be used. In each village, a health promotion council consisting of stakeholders is formed. After the formation of self-help groups, capacity building is done with self-care topics in hypertension. The study is designed in such a way that it causes involvement, participation and empowerment of the intervention group. The control group only receives the routine programs of the health system.
Main outcome variables
Perception of hypertension disease, empowerment, self-care behaviors in hypertension, blood pressure
General information
Reason for update
The recruitment date of the participants has changed.
Acronym
IRCT registration information
IRCT registration number:IRCT20231213060354N1
Registration date:2023-12-24, 1402/10/03
Registration timing:prospective
Last update:2024-04-29, 1403/02/10
Update count:1
Registration date
2023-12-24, 1402/10/03
Registrant information
Name
Hassan Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3333
Email address
hassann1811@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of community-based intervention through planned approach to community health(PATCH) on disease perception, empowerment and self-care behaviors of patients with hypertension
Public title
Assessing the effectiveness of community-based intervention through planned approach to community health(PATCH) on disease perception, empowerment and self-care behaviors of patients with hypertension
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from hypertension
Registered in the Sib system
Exclusion criteria:
Dissatisfaction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
428
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate health homes to two intervention and control groups, a block random allocation protocol (produced by Random Allocation Software) with blocks of 4 will be used.
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
Research Ethics Committees of School of Public Health & Allied Medical Sciences- Tehran University o
Street address
Elkhebal St., Quds St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-12-13, 1402/09/22
Ethics committee reference number
IR.TUMS.SPH.REC.1402.245
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-care behaviors in hypertension
Timepoint
It will be done before the start of the study and 6 months after the start of the study.
Method of measurement
The Persian version of the self-care behavior measurement tool in hypertensive patients was made by Han et al. at Johns Hopkins University, and its psychometrics in Farsi were done by Qanei et al.
Secondary outcomes
1
Description
Perception of the disease
Timepoint
Perception of the disease will be tested at the beginning of the study and three months after the start of the study.
Method of measurement
The questionnaire of perception of high blood pressure disease was made by Kamran et al.
2
Description
Empowerment
Timepoint
Perceived control scale: An Empowerment Index will be tested at the beginning of the study and three months after the start of the study.
Method of measurement
Perceived Control Scale: An Empowerment Index developed by Barbara Israel and adapted by Asadi Psychoanalyst.
3
Description
better control of hypertension
Timepoint
Blood pressure will be tested at the beginning of the study and six months after the start of the study.
Method of measurement
The measurement of blood pressure (systole and diastole) will be done by means of a standard sphygmomanometer, Zenit Mod, model ZTH 5001, made in Switzerland, whose accuracy has been checked and confirmed with a calibration device.
Intervention groups
1
Description
Intervention group: There are people with high blood pressure who will be selected from different villages. The reason for choosing the village for the intervention is that the planned approach to community health is a community-oriented approach that is based on empowering communities to change health behaviors in communities and is based on relationships within and between communities. Then we will form a self-help group among them. The required number of samples will be extracted by simple random from the list of patients with high blood pressure from the apple system, based on the entry and exit criteria in each health center separately. In total, taking into account the sample size formula and taking into account 20% attrition and also according to the number of selected centers, the names of 428 people (214 people, intervention group and 214 people, control group) will be extracted. The place of study (research environment) is the villages of Babol city. In this study, among the approaches and models such as participatory action research, multi-level approach to community health, ecological models, planned approach to community health, Persid-Prosid model, etc., from the planned approach to community health In the direction of community-oriented planning, it is used to promote the participation and empowerment of participants in different stages of understanding the problem and capacities, achieving solutions, implementation and evaluation, in which people who are affected by an issue; They play a role in solving the problem. This approach because of its special features; selected for this study. The most important feature of the planned approach to community health, in addition to the participatory nature of the planning process, is social mobilization and communication within and between communities. In this study, this approach will be effective for social mobilization by forming the health promotion committee and self-help groups at the village level and establishing communication between and within them and conducting intervention at these levels. The formation of committees and working groups is actually the first stage of the approach, that is, community mobilization, which can participate in community-oriented planning. The stages of intervention planning with a participatory approach based on the planned approach to community health are as follows: a) community mobilization b) data collection c) problem analysis and priorities d) program formulation e) implementation f) evaluation In this group, as explained before; Before the intervention, a pre-test will be conducted with tools to measure perception, ability, and self-care behaviors in hypertension. Blood pressure will also be measured and recorded in them. Three months after the start of the intervention, they will be evaluated in terms of perception and ability. At the end of the sixth month, their self-care behaviors are examined and their blood pressure is measured.
Category
Lifestyle
2
Description
In the control group, a pre-test will be conducted in terms of perception, ability, and self-care behaviors in hypertension. People's blood pressure will also be measured and recorded. This group will only receive routine care. Then, at the end of the third month, they will be tested in terms of perception and ability, and at the end of the sixth month, they will be tested in terms of self-care behaviors in hypertension, and their blood pressure will be measured again.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
in the villages of Babol city
Full name of responsible person
Dr. Roya Sadeghi
Street address
Comprehensive rural health service centers of Babol city
City
Babol
Province
Mazandaran
Postal code
۳۴۹۳۷_۴۷۱۴۹
Phone
+98 11 3233 2876
Fax
+98 11 3236 3875
Email
health@mubabol.ac.ir
Web page address
https://health.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Street address
Elkhebal St., Quds St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Fax
+98 21 8898 9131
Email
sph@tums.ac.ir
Web page address
https://sph.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
2
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
حسن حیدری
Street address
Modares St., Bagh Ferdous, Babol health department (city health center)
City
Babol
Province
Mazandaran
Postal code
۳۴۹۳۷۴۷۱۴۹
Phone
+98 11 3233 2876
Fax
+98 11 3236 3875
Email
health@mubabol.ac.ir
Web page address
https://health.mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Dr. Roya Sadeghi
Position
Professor of Health Faculty of Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Elkhebal St., Quds St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3055
Fax
+98 21 4293 3072
Email
sadeghir@tums.ac.ir
Web page address
https://sph.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
Professor of Health Faculty of Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Elkhebal St., Quds St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3055
Fax
+98 21 8898 9131
Email
sadeghir@tums.ac.ir
Web page address
https://sph.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hassan Heydari
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Elkhebal St., Quds St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Fax
+98 21 8898 9131
Email
hassann1811@gmail.com
Web page address
https://sph.tums.ac.ir
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
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Blood pressure level, perception of the disease, ability and self-care of hypertension
When the data will become available and for how long
unlimited
To whom data/document is available
Supervisor, second supervisor, project advisors and students
Under which criteria data/document could be used
For analysis and use in similar communities
From where data/document is obtainable
student
What processes are involved for a request to access data/document
Written request, appearing in the meeting and making a decision