Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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Sampling will be cluster random. The location of the study is the villages of Babol city.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Perception of hypertension disease, empowerment, self-care behaviors in hypertension, blood pressure
General information
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Reason for update
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The recruitment date of the participants has changed.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-12-24, 1402/10/03
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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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2024-05-21, 1403/03/01
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Expected recruitment end date
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2024-06-21, 1403/04/01
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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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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
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Public title
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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
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Purpose
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Other
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Inclusion/Exclusion criteria
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Inclusion criteria:
Suffering from hypertension
Registered in the Sib system
Exclusion criteria:
Dissatisfaction
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Age
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No age limit
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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:
428
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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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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Parallel
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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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2023-12-13, 1402/09/22
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Ethics committee reference number
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IR.TUMS.SPH.REC.1402.245
Health conditions studied
1
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Description of health condition studied
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hypertension
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ICD-10 code
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I10
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ICD-10 code description
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Essential (primary) hypertension
Primary outcomes
1
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Description
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Self-care behaviors in hypertension
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Timepoint
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It will be done before the start of the study and 6 months after the start of the study.
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Method of measurement
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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
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Description
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Perception of the disease
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Timepoint
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Perception of the disease will be tested at the beginning of the study and three months after the start of the study.
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Method of measurement
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The questionnaire of perception of high blood pressure disease was made by Kamran et al.
2
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Description
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Empowerment
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Timepoint
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Perceived control scale: An Empowerment Index will be tested at the beginning of the study and three months after the start of the study.
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Method of measurement
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Perceived Control Scale: An Empowerment Index developed by Barbara Israel and adapted by Asadi Psychoanalyst.
3
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Description
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better control of hypertension
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Timepoint
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Blood pressure will be tested at the beginning of the study and six months after the start of the study.
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Method of measurement
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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
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Description
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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.
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Category
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Lifestyle
2
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Description
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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.
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Category
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Lifestyle
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
2
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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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No
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Blood pressure level, perception of the disease, ability and self-care of hypertension
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When the data will become available and for how long
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unlimited
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To whom data/document is available
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Supervisor, second supervisor, project advisors and students
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Under which criteria data/document could be used
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For analysis and use in similar communities
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From where data/document is obtainable
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student
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What processes are involved for a request to access data/document
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Written request, appearing in the meeting and making a decision
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Comments
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