Evaluation of the effectiveness of physician communication training on level of patient’ health literacy skills and hypertension outcome among patients with uncontrolled blood pressure.
Design
A randomized controlled trial method was used to enroll 242 hypertensive patients and 35 physicians from healthcare clinics in the Mashhad, Iran.
All participants received a code, then, they were randomly divided into two control and intervention groups. Multiple statistical analysis were used to assess whether the physician training improved physicians-patient's communication skills, hypertension outcomes, self- efficacy, and patient medication adherence after intervention.
Settings and conduct
The study population was women and men who referred to health centers in Mashhad, Iran. 6 Clinics were randomly assigned (as the unit of randomization) to either usual care control (n = 3 clinics) or the training intervention (n = 3).
Participants/Inclusion and exclusion criteria
They have uncontrolled blood pressure, age 18 or older, could speak and read Farsi، able to give informed consent, did not suffered an acute-myocardial infarction or had kidney disease and other health impairments
Intervention groups
All participants were allocated into an educational intervention group and control group. In intervention group, the educational intervention was conducted based on the potential communication gaps with focus on Health Literacy in Practice (HLP) strategies. The control group did not receive any intervention education.
Main outcome variables
Hypertension outcomes; physicians-patient's communication skills; Self- efficacy; patient medication adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160710028863N24
Registration date:2018-04-04, 1397/01/15
Registration timing:prospective
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
Nooshin Peyman
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 502 6195
Email address
peymann@mums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2634-11-22, 2013/09/01
Expected recruitment end date
2635-11-19, 2014/08/28
Actual recruitment start date
2634-11-22, 2013/09/01
Actual recruitment end date
2634-12-22, 2013/10/01
Trial completion date
empty
Scientific title
Effect of a Physicians Communication Skills Training on Health Outcomes and HealthLiteracy Among Hypertensive Patients: a Randomized Controlled Trial
Public title
Effect of a Physicians Communication Skills Training on Health Outcomes Among Hypertensive Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All eligible patients included if they had to be have uncontrolled blood pressure
prescribed at least one antihypertensive medication during the past three months
were age 18 or older
could speak and read their native language in Iran (Persian)
Exclusion criteria:
They were unable to give informed consent
had suffered an acute-myocardial infarction or had kidney disease
had visual impairment, mental disturbance illiteracy, and upper limb disability
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
940
Actual sample size reached:
242
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling was used to select eligible patients with hypertension from the six primary care clinics in Mashhad, Iran. Health secretaries provided different lists of patients and all the patients are assigned number. The researcher then used tables of random number to select each number of the patients. 940 patients with hypertension were randomly screened, of whom 698 were excluded for several reasons such as they did not meet the inclusion criteria. Of the final 242 enrolled patients enrolled for the initial study were randomly assigned to intervention (n= 121) and control groups (n=121).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
.
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Research Committee
Street address
Daneshgah Street, between Daneshgah 16 -18
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2634-11-22, 2013/09/01
Ethics committee reference number
IR.MUMS.REC.1392.125
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension, high blood pressures associated with health literacy and health outcome
Primary outcomes
1
Description
hypertension outcomes (SBP and DBP)
Timepoint
The beginning of the study (before the intervention)، after intervention, and six months after the intervention
Method of measurement
Automated blood pressure monitor
2
Description
patient’s Health literacy skills
Timepoint
The beginning of the study (before the intervention)، after intervention, and six months after the intervention
Method of measurement
International questionnaire of Health Literacy in Practice (HLP) strategies
Secondary outcomes
1
Description
self-efficacy
Timepoint
The beginning of the study (before the intervention)، after intervention, and six months after the intervention
Method of measurement
The International chronic disease self-efficacy Questionnaire
2
Description
Patient's medication adherence
Timepoint
The beginning of the study (before the intervention)، after intervention, and six months after the intervention
Method of measurement
The Adult Primary Care Questionnaire was used to assess medication adherence.
Intervention groups
1
Description
Intervention group: physicians-patient’s training to address key disparities based on Health Literacy in Practice (HLP) strategies among hypertensive patient
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
six government primary care clinics
Full name of responsible person
Dr Nooshin Peyman
Street address
Department of Health Education and Health Promotion, Danshgah Street, between Daneshgah 16-18
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3893 9832
Email
Peymann@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi (Pharm.D, Ph.D)
Street address
Mashhad University of Medical Sciences International Office, Administration Center (Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3180 1337
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Belin Tavakoly Sany
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Environmental Health
Street address
Department of Health Education and Health Promotion, between 16th and 18th Daneshgah, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 4643
Email
tavakkolisb2@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Belin Tavakoly Sany
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Environmental Health
Street address
Department of Health Education and Health Promotion, Daneshgah Street, between Daneshgah 16 -18
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 3007
Email
tavakkolisb2@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Belin Tavakoly Sany
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Environmental Health
Street address
Department of Health Education and Health Promotion, Daneshgah Street, between Daneshgah 16 -18
City
Mashhad
Province
North Khorasan
Postal code
9138813944
Phone
+98 51 3841 3007
Email
tavakkolisb2@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Dr Nooshin Peyman
Peymann@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email