Determining the effect of community-based interventions on improving the lifestyle of elderly people with high blood pressure in Khorramabad city based on the health belief model.
Design
Clinical trial, with control group, random stratified blocking.
Settings and conduct
The present study is a clinical trial study of Shahdar, on the elderly with hypertension, referring to the comprehensive health centers of Khorramabad with the method of sampling stratified random blocks in 2019-2020.Data Gathering Tools, Demographic Questionnaire,Hill-Bone treatment adherence scale, Assessment of Elderly Physical Activity (PASE),The study of perceptions and nutritional status in the elderly with hypertension is designed based on awareness structures, self-efficacy, commitment to program implementation and dietary follow-up of the health promotion model. Using 2.1, 3 Gpower software (due to the complexity of the formula cannot be calculated manually),
Participants/Inclusion and exclusion criteria
1- Having an age of 84-60 years
2- Mild to moderate blood pressure
3- No history of vascular disease 4- no mobility problems
5- Tendency to participate in research, speaking in Persian, Lori and laki 6- Lack of hearing and speech problems 7- Elderly death
Intervention groups
It includes a number of elderly men and women aged 84-60 years (eligible) with high blood pressure who are covered by comprehensive health centers selected for research in 2019-2020.
Main outcome variables
Physical activity- Nutritional Perceptions- Adherence to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180721040540N4
Registration date:2020-05-21, 1399/03/01
Registration timing:prospective
Last update:2020-05-21, 1399/03/01
Update count:0
Registration date
2020-05-21, 1399/03/01
Registrant information
Name
Heshmatolah Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0160
Email address
heidari.h@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-25, 1399/03/05
Expected recruitment end date
2020-11-25, 1399/09/05
Actual recruitment start date
2020-11-25, 1399/09/05
Actual recruitment end date
2020-11-25, 1399/09/05
Trial completion date
2020-12-25, 1399/10/05
Scientific title
TThe Effect of Community Based Interventions on Promoting the Life Style of Elderly People with Hypertension Based on Health Belief Model in 1398
Public title
The Impact of Community-Based Interventions on Promoting Lifestyle
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
60-84 years old
Hypertension based on the diagnosis of a specialist (duration of at least 12 months).Take at least one blood pressure lowering medication or change lifestyle for control.
Confirmation of entry for study by physician designated research centers
hypertension have (140/90 -159/99 mmHg mild hypertension)
hypertension have (160/100-179 /109 mmHg medium Hypertension)
No need for surgical treatment in recent months
No history of coronary artery disease,Kidney
Lack of physical disability or mental disorder
Minimum literacy
No mobility problems (able to perform daily activities without dependence on others)
Lack of cognitive impairment and severe disabilities in walking independently (Walker, Wheelchair Dependency)
Willingness to participate in research
Spoken in Farsi, Larry and Lucky
Lack of hearing and speech problems
Exclusion criteria:
Recent history for advanced and malignant disease
Taking psychotropic drugs
Drug use
Age
From 60 years old to 84 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling was convenience method. Eligible subjects with using the Permuted block randomization will have located in the intervention or control groups. The Sex(Male and female), and level of hypertension of subjects, will consider as stratified in the inside of blocks.
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 in Research of Lorestan University of Medical Sciences
Street address
Kelometr 5 Kamalvand Khoramabad- Boroujerd Road, Lorestan University Of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.LUMS.REC.1399.039
Health conditions studied
1
Description of health condition studied
Improving the lifestyle of the elderly with hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
physical activity
Timepoint
Before, one month, two months and three months later
Method of measurement
Questionnaire of Physical activity scale for the elderly
2
Description
Nutritional perceptions
Timepoint
Before, one month, two months and three months later
Method of measurement
Questionnaire
3
Description
Adherence to treatment
Timepoint
Before, one month, two months and three months later
Method of measurement
Adherence to Hill-Bone High Blood Pressure Treatment
4
Description
Self- efficacy
Timepoint
Before, one month, two months and three months later
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Blood pressure changes
Timepoint
Before, one month, two months and three months later
Method of measurement
Mercury manometer
Intervention groups
1
Description
Intervention group: The interventions in this s sessions based on the health belief model, The researcher teaches the elderly and their caregivers about the importance of diet, timely use of prescribed medications and physical activity.The workshop sessions will be conducted in a workshop manner (lectures, questions and answers, and a review of the content of the previous session) along with the presentation of educational booklet with very simple content. The duration of group training will be between 30 and 40 minutes in comprehensive health centers or any place where the individual and her family are available and have full satisfaction with the location of the training.Training sessions will be intervened 24 times during 3 months and will be held 2 days a week according to the conditions of the elderly studied.Individual home training will take place two weeks after group training. In addition, the researcher will be in constant contact tudy will include trainingwith the samples in person or by phone during this period.The contents of the booklet include explanations on how to consume age-appropriate diets rich in protein, milk, and low-fat products to strengthen bones, fish consumption, andBrains such as almonds and walnuts and whole grains and fruits and vegetables as well as side effectsTheir medications and the effect of exercise on vitality and health and the effects of high blood pressure as well as the need Medical follow-up will be in collaboration with a cardiologist and nutritionist.Control group: They will receive their usual care from the health staff and at the end of the study, educational interventions will be provided to this group.
Category
Behavior
2
Description
Control group: the control group will receive routine services of comprehensive health centers.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Heshmatolah Heydari
Street address
Kilometr 5 Khorramabad- Boroujerd Road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Hidari74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Fallahi
Street address
Kilometr 5 Khorramabad- Boroujerd Road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0172
Fax
+98 66 3312 0173
Email
research@lums.ac.ir
Web page address
http://research.lums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatolah Heydari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kilometr 5 Khorramabad- Boroujerd Road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Hidari74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Heshmatolah Heydari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kilometr 5 Khorramabad- Boroujerd Road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 1233 0174
Fax
+98 66 1233 0173
Email
hidari74@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatolah Heydari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kiloumetr 5 Khorramabad- Boroujerd Road
City
Khorramabad
Province
Lorestan
Postal code
6815644667
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Hidari74@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
Because of confidentiality
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
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
The final report of the dissertation and questionnaires will be shared
When the data will become available and for how long
After final registration of the dissertation and publication of articles related to the project
To whom data/document is available
esearch team members, university research officials, project supervisors, editors of special journals، Researchers in the field of medical sciences
Under which criteria data/document could be used
Doing research to improve the lifestyle of the elderly
From where data/document is obtainable
Responsible researcher
What processes are involved for a request to access data/document
Coordinating with the researcher through email, Refer to the library of the Faculty of Nursing, Lorestan University of Medical Scienc