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The effect of group training and tele-nursing on medication/diet adherence and blood pressure control in the elderly with hypertension

Protocol summary

Study aim
Determining the effect of group training and tele-nursing on adherence to diet, diet and blood pressure control in the elderly with hypertension
Design
Using the balance block randomization approach, individuals will be assigned to three groups of 30, including tele-nursing, group training, and random allocation control. First, written consent will be obtained from all selected individuals, emphasizing the confidentiality of information, and then individuals will be divided into one of three groups, including 1- tele-nursing, 2- group training, and 3- control.
Settings and conduct
Ilam province, Abdanan city
Participants/Inclusion and exclusion criteria
At least six months have passed since the diagnosis of hypertension. Do not have speech, hearing or vision problems. Be literate. Be able to understand conversation in Persian and Kurdish. It is possible to make direct telephone calls to the patient.
Intervention groups
Basic information will be collected from all groups. in this study, the pressure level of the participants is measured. control group will have no intervention but the study of a booklet. A 6 - week training intervention will continue. Topics will include explanations of high blood pressure and its control procedure, the right to measure the blood pressure pressure, the healthy diet, weight control, interruption of smoking, and adherence to consumption, stress management and anxiety, physical activity, monitoring of care, and For the participants participating in the category of group training for six weeks, a 45 - 60 - minute training session is considered every week. For the تله Company for 6 weeks, 2 - 20 minutes each week is considered to be 10 - 20 minutes
Main outcome variables
medication adherence؛ diet adherence؛ blood pressure control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220130053886N1
Registration date: 2022-07-16, 1401/04/25
Registration timing: retrospective

Last update: 2022-07-16, 1401/04/25
Update count: 0
Registration date
2022-07-16, 1401/04/25
Registrant information
Name
RAZIEH MOHAMADZADEH
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3362 2636
Email address
razi.m1376@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group training and tele-nursing on medication/diet adherence and blood pressure control in the elderly with hypertension
Public title
effect of group training and tele-nursing on medication/diet adherence and blood pressure control
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Their age is 60 to 74 years. Be at least six months have passed since the diagnosis of hypertension. Do not have speech, hearing or vision problems. Be literate. Be able to understand conversation in Persian and Kurdish. It is possible to make direct telephone calls to the patient. Do not suffer from debilitating physical and mental illnesses (stroke, Parkinson's, multiple paralysis, epilepsy, depression, etc.). Lack of employment in the treatment staff
Exclusion criteria:
For whatever reason, they can not follow the training program. Do not attend more than one in-person or telephone session. Hospitalization or death during the study. Do not want to continue reading.
Age
From 60 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
According to the equal proportion of people covered by each center, based on the entry and exit criteria, 18 to 22 people will be selected from each center until the desired sample size (90 people) is provided. Then, using the balance block randomization approach, individuals will be given to three groups of 30 people, including tele-nursing, group training, and random allocation control. To perform balance block randomization, 3 permutations will be determined first, which include the following order: 1: ABC 2: BAC 3: BCA 4: CAB 5: CBA 6: ACB A will be the symbol of the group training group, B will be the symbol of the tele-nursing group and C will be the symbol of the control group. Then, using stata software and alloc package, a random sequence will be created and each person who enters the study will be assigned to groups based on this sequence.
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 Ilam University of Medical Sciences
Street address
Shahid Norouzi Alley, Shahriar St, Baqer Sadr, Abdanan
City
Abdanan
Province
Ilam
Postal code
6971863311
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.MEDILAM.REC.1400.245

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
blood pressure control
Timepoint
Measurement of blood pressure before the intervention and every week until the end of the study
Method of measurement
Using a sphygmomanometer

2

Description
medication adherence
Timepoint
Before the intervention began, and at the end of the intervention, and again a month after the intervention ended
Method of measurement
hell bone questionnaire

3

Description
diet adherence
Timepoint
Before the intervention began, and at the end of the intervention, and again a month after the intervention ended
Method of measurement
hell bone questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: group training. A small group of people is assembled in a peaceful environment, and after training on blood pressure and its way of controlling it, the researcher is allowed to interact with each other about the issue discussed. For the participants participating in the category of group training for six weeks, a 45 - 60 - minute training session is considered every week.
Category
N/A

2

Description
Intervention group2: tele-nursing. the purpose of this study is to provide training and follow - up patients with پرفشاری blood pressure by the researcher over the past six weeks and twice a week. Over the course of the phone conversation, about 10 to 20 minutes and phone conversations include information on diet, diet, lifestyle, and answers to their questions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Abdanan County Health Network
Full name of responsible person
Dr Saman Rashidi
Street address
Imam Khomeini street
City
Abdanan
Province
Ilam
Postal code
6971863311
Phone
+98 84 3362 4052
Email
msa.aghili@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Kafashian
Street address
Ilam University of Medical Sciences Campus, Research Blvd, Banganjab, Ilam.
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3333 4060
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Dr Afsane Raiesi far
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ilam, Banganjab, Research Blvd., Ilam University of Medical Sciences Campus
City
ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3333 4060
Email
a.raiesifar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Afsane Raiesi far
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ilam, Banganjab, Research Blvd., Ilam University of Medical Sciences Campus
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3333 4060
Email
a.raiesifar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Afsane Raiesifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ilam, Banganjab, Research Blvd., Ilam University of Medical Sciences Campus
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3333 4060
Email
a.raiesifar@gmail.com

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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