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The effect of activity and spiritual health based self-care program on hypertension among the Kahrizak elderly people in the Alborz province.

Protocol summary

Study aim
1-Determining the Effectiveness of Self-Care-Based Activity Program - Spiritual Health on Hypertension in Kahrizak Alborz Elderly
Design
This study is a clinical trial with three groups: control group, self-care program group and activity group, purposeful and pragmatic, single blind and non-randomized.
Settings and conduct
Study place: Alborz Provincial Kahrizak Care Center, Mohammad Shahr, Karaj, Iran
Participants/Inclusion and exclusion criteria
1-Elderly diagnosed by a specialist physician residing in a hypertensive center 2-The patient's age is 65 to 90 years. Because they have at least one chronic disease, according to the sources of people over the age of 60 years Non-arrival conditions like: 1. During the study of elderly death or leaving the sanatorium for any reason. 2. During the study, you are suffering from diseases caused by hypertension or heart attacks.
Intervention groups
For the 30 elderly in the control group, the activity and self-care program of the consent form of the company were completed in the research, and the demographic information, daily life and spiritual well-being questionnaires were completed. Systolic and diastolic blood pressure was measured with a barometric device at two times in the morning and evening for three consecutive days and recorded in the blood pressure check list. For the elderly, the intervention group was first trained in two sessions of 30-45 minutes about the purpose of the study, its elderly age and its accompanying problems, the role of exercise and physical activity in controlling hypertension. For the self-care program group, the spiritual health program was presented about value-hosts. In the implementation section, the activities were carried out according to what was taught.
Main outcome variables
The rate of hypertension, self-care and activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180527039870N1
Registration date: 2018-07-04, 1397/04/13
Registration timing: retrospective

Last update: 2018-07-04, 1397/04/13
Update count: 0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Saeedeh Khalili
Name of organization / entity
The University ofTarbiyat modares
Country
Iran (Islamic Republic of)
Phone
+98 26 3730 4592
Email address
saeedehkhalili@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
2017-03-19, 1395/12/29
Actual recruitment end date
2017-09-06, 1396/06/15
Trial completion date
empty
Scientific title
The effect of activity and spiritual health based self-care program on hypertension among the Kahrizak elderly people in the Alborz province.
Public title
The effect of self-care program on hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly diagnosed as hypertensive disease by a specialist physician residing in center. The age of the patient is 65 to 90 years old. Older people have read and write literacy or ability to interview. Have a tendency to participate and collaborate in research.
Exclusion criteria:
Illnesses caused by complications of hypertension or myocardial infarction during the study. Elderly death or leaving the sanatorium for any reason during the study
Age
From 65 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Actual sample size reached: 89
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study were placed in separate groups so that they did not deal with each other
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modarres University
Street address
Tehran Jalal Al Ahmad Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2016-12-11, 1395/09/21
Ethics committee reference number
IR.TMU.REC.1395.431

Health conditions studied

1

Description of health condition studied
hypertension in the elderly
ICD-10 code
110
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Percentage of people with hypertension above 140/90
Timepoint
Measuring hypertension at the beginning of the study three consecutive days at two times in the morning and at night, and then at the end of the study three consecutive days at two times in the morning and evening after the presentation of the training program
Method of measurement
Yamasu counter barometer

Secondary outcomes

empty

Intervention groups

1

Description
Control group: For 30 elderly people in the control group consent to participate in research and demographic, complete with Shd.fsharkhvn systolic and diastolic pressure gauge Japanese Yamasv in the morning and afternoon on three consecutive days to measure and record blood pressure at the Czech medical records and in the last 1.5 months without intervention seniors again in the morning and evening blood pressure measurements were recorded in the Czech list.
Category
Rehabilitation

2

Description
Intervention group: For the 30 aged people in the activity group, at first, the satisfaction of the company in the research and the demographic information questionnaire, the daily routine life questionnaire was completed for elderly in terms of physical activity and resting time during physical or physical activity. Then, elderly blood pressure at two times in the morning The age of measurement was recorded in the blood pressure check list. In the implementation section, the items of the daily life activity questionnaire were explained to the elderly in 5 dimensions and they were asked to perform their duties and duties according to the items of the daily life activities questionnaire. And register in the self-report checklist. In the follow up section, the researcher's presence was followed up within 3 weeks of the elderly's performance. At the end of the first 1.5 months, the questionnaire was completed daily living and elderly blood pressure was measured at two times in the morning and in the evening and recorded in the checklist.
Category
Rehabilitation

3

Description
Intervention group: For the 30 elderly in the self-care program group (spiritual activity), the consent of the company in the research and the demographic information questionnaire, the daily living practice questionnaire for assessing the elderly in terms of physical activities and resting time during physical or physical activity, as well as the questionnaire Spiritual health was completed. In the implementation section, the activities were followed in the same way as the second intervention group, and the spiritual health program was presented in different fields such as values (encouragement to help others), connecting point (listening to the verses of the verse, 3 times a week). 1.5 months later. The intervention was again completed and scaled.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kahrizak Center for Alborz Province
Full name of responsible person
Saeedeh Khalili
Street address
Mohammad Shahr, at the end of Golestan St., Beginning of Isfahan Street
City
Karaj
Province
Alborz
Postal code
167-31845
Phone
+98 26 3630 1858
Email
sos.khalili@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tarbiat modares
Full name of responsible person
Yaghoub Fathollahi
Street address
Nasr briddge, Jalal All Ahmad, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3108
Email
saeedehkhalili@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tarbiat modares
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
Tarbiat Modares University
Full name of responsible person
Saeedeh Khalili
Position
MSc student of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nasr briddge, Jalal All Ahmad St., Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3108
Email
saeedehkhalili@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Saeedeh Khalili
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nasr Briddge, Jalal All Ahmad St., Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 82883108
Email
saeedehkhalili@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Saeedeh Khalili
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nasr Briddge, Jalal All Ahmad St., Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 82883108
Email
saeedehkhalili@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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