"determine Comparing the effect of two methods of teach back and motivational interview on the therapeutic regimen adherence in patients with hypertension"
Design
In this study, 81 patients with hypertension who visit the Shaheed Mofateh Clinic in Yasuj and have the inclusion criteria will be selected. Participants will be randomly allocated in two groups of intervention and control, and a code will be assigned for each participant.
Settings and conduct
Shahid Mofateh medical Clinic of Yasuj City
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Acquire undesirable score (less than 50 percent of 100 percent of two scales diet, exercise and medicines) follow the questionnaries from people diet that they afflicts with hypertension
Exclusion criteria:
Participation in the training course on blood pressure in the last 6 months
History of chronic diseases including chronic kidney disease, chronic renal parenchymal, renal artery stenosis, history of nephrectomy, renal surgery
Intervention groups
Teach back intervention group: Intervention group1: The tutorial will be run using the teach-back method. Educational content will be taught to the patient by a face-to-face researcher in plain language without the use of medical terminology. The patient is then asked to express the educational content in his / her own language. If the patient does not understand correctly, the content will be re-educated.
Motivational interview intervention group: the group intervention will be performed in 8-12 people groups. A total of 5 interview sessions will be held within 2 months for each group with a duration of 60 to 90 minutes for each session.
Main outcome variables
Adherence to the treatment regimen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180711040430N1
Registration date:2019-01-08, 1397/10/18
Registration timing:retrospective
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Maryam Alishapour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 2223 4115
Email address
maryam.alishapour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-15, 1397/06/24
Expected recruitment end date
2018-11-15, 1397/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two methods of teach back and motivational interview on the therapeutic regimen adherence in patients with hypertension
Public title
Comparing the effect of two methods of teach back and motivational interview on the therapeutic regimen adherence in patients with hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy
Hearing and speaking ability
At least 6 months passed of hypertension diagnosis
Diagnosis of primary hypertension by the physician
Consent to participate in the study
Age of 35 to 60 years' old
Exclusion criteria:
Participation in the training course on blood pressure in the last 6 months
History of chronic diseases including chronic kidney disease, chronic renal parenchymal, renal artery stenosis, history of nephrectomy, renal surgery, endocrine diseases including pheochromocytoma and Cushing’s syndrome
Taking contraceptive pills 6 months before the intervention
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocated in two groups of intervention and two group control, and a code will be assigned for each participant
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yasouj University of Medical Sciences
Street address
Management of medical science.,Vice President of Research and Technology,University of Medical Sciences.,Blvd martyr Motahhari.,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2018-09-08, 1397/06/17
Ethics committee reference number
IR.YUMS.REC.1397.075
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
therapeutic regimen adherence
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Using the questionnaire of adherence of hypertensive patients to treatment regimen
2
Description
Blood pressure
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Manometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teach Back method for three sessions of an hour each The tutorial will be run using the teach-back method. Educational content will be taught to the patient by a face-to-face researcher in plain language without the use of medical terminology. The patient is then asked to express the educational content in his / her own language. If the patient does not understand correctly, the content will be re-educated .
Category
Behavior
2
Description
Intervention group: In this study, motivational interviewing in the intervention group runs in the fifth sessions.the structure of weekly meetings extracted from a motivational interviewing group intervention book with a five-session structure.Contents of the Motivational interviewing session: • First session (dating): A group norms and processes, facilitates the philosophy, practice of freedom, the exercise of Dimensions of behavior influence, the exercise of change cycle assessment of commitment and confidence. • Second session (emotion): Feelings Practice identifying, practicing and perfecting the exercise of influence dimension and emotional dimension and homework. • The third session (positive and negative aspects of behavior and change): Practice of brainstorming of Short-term and long-term profit and losses, Practice of complete table of the positive and negative aspects, describe and Practice of corrective options and alternatives one. • Fourth session (values): Definition of values, Practice of identifying and prioritizing notch values, practice to define values and value-behavior consistency. • Fifth session (closing Landscape): Summarizing and concluding of previous training Sessions in a Landscape practice and preparation for the start of behavior change programs.
Category
Behavior
3
Description
Control group: patients will not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofatheh Yasuj medical Clinic
Full name of responsible person
Soheila zabolipour
Street address
St Shahid Mohammad Montazeri.,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591714983
Phone
+98 74 3323 2750
Email
S_zabolipour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology,Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari Oryad
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, ShahidMotahary Blvd. Yasuj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591714983
Phone
+98 74 3323 4115
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology,Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Maryam Ali Shapour
Position
Master student of Medical-Surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing Midwifery., St. Martyr Dr. Jalil.,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Email
maryam.alishapour@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Soheila zabolipour
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing , Shahid Dr. Jalil St., Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Email
S_zabolipour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Maryam Alishapour
Position
Master student of Medical-Surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Eram Blvd.,Yasouj.,Iran
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7585133446
Phone
+98 74 3322 1288
Email
maryam.alishapour@yums.ac.ir
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
Triages that began to fall ill on January 11, 1397 should have a release plan when registering their study protocol.