The current survey aimed to investigate the motivational interviewing effects as a new technique compared to the usual care among hypertensive Iranian patients.
Methods: A randomized control trial was implemented. Participants of 140 were allocated in the two groups, randomly included motivational interviewing (intervention group) and usual care (control group). The intervention was done through a psychologist who was authorized, each group ranged from 7 to 10 subjects that trained for 6 sessions over six months (45 to 60 minutes for each session); while, usual education was done by a health center staff using a lecture and pamphlet about hypertension for six months (each session sized from 7 to 10 samples and was 30 to 45 minutes and 1 session per month), Inclusion criteria were as follows: 1) patients diagnosed with hypertension by a physician; 2) patients who received one antihypertensive medication at least; 3) patients who agreed to participate in the survey and more than 18 years old. Excluded criteria were as: 1) pregnant women and being pregnant during the study and 2) secondary hypertensive patients. The main variables were behavior change of patients about regular physical activity, healthy dietary habits, smoking cessation, reducing stress and adherence to medication that tested in pre-test and 6 month follow- up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014113017736N3
Registration date:2014-12-15, 1393/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-15, 1393/09/24
Registrant information
Name
Seyed Kamaladdin Mirkarimi
Name of organization / entity
Golestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 1553 2872
Email address
k.mirkarimi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2014-02-05, 1392/11/16
Expected recruitment end date
2014-11-02, 1393/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Motivational Interviewing Effects on Hypertensive Patients attended to health centers of Gorgan city in 2014
Public title
Motivational Interviewing Effects on Hypertensive Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria were as follows: 1) patients diagnosed with hypertension by a physician; 2) patients who received one antihypertensive medication at least; 3) patients who agreed to participate in the survey and more than 18 years old. Excluded criteria were as: 1) pregnant women and being pregnant during the study and 2) secondary hypertensive patients.
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Science
Street address
4 Kilometer of Gorgan-Sari road, Falsafi educatiobal campus, technology and research department
City
Gorgan
Postal code
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
930942173
Health conditions studied
1
Description of health condition studied
Healthy lifestyle
ICD-10 code
Z91.8
ICD-10 code description
Maltreatment NOS
Primary outcomes
1
Description
The laboratory and clinical indices (systolic blood pressure, the diastolic blood pressure, triglyceride level and total cholesterol, the symptoms of hypertension, and the complications of hypertension)
Timepoint
Baseline (pre-test)
Method of measurement
Laboratory and clinical sheet
2
Description
Blood pressure
Timepoint
Baseline (pre-test)
Method of measurement
Blood test, when patient in sitting position, 5 minutes after sitting from the left arm
3
Description
Treatment Adherence
Timepoint
Baseline (pre-test)
Method of measurement
Treatment Adherence Questionnaire of Patients with Hypertension (TAQPH)
4
Description
Demographic status (included age, gender, marital status, educational level and diagnosis duration)
Timepoint
Baseline (pre-test)
Method of measurement
Demographic questionnaire
5
Description
Self-efficacy
Timepoint
Baseline (pre-test)
Method of measurement
General Self-Efficacy Scale (GSES)
6
Description
Quality of life
Timepoint
Baseline (pre-test)
Method of measurement
Medical outcomes study 36- item short form (SF-36)
Secondary outcomes
1
Description
Quality of life
Timepoint
Follow-up after 6 month
Method of measurement
Medical outcomes study 36- item short form (SF-36)
2
Description
Self-efficacy
Timepoint
Follow-up after 6 month
Method of measurement
General Self-Efficacy Scale (GSES)
3
Description
Treatment Adherence
Timepoint
Follow-up after 6 month
Method of measurement
Treatment Adherence Questionnaire of Patients with Hypertension (TAQPH)
4
Description
The laboratory and clinical indices (systolic blood pressure, the diastolic blood pressure, triglyceride level and total cholesterol, the symptoms of hypertension, and the complications of hypertension(
Timepoint
Follow-up after 6 month
Method of measurement
Laboratory and clinical sheet
5
Description
Blood pressure
Timepoint
Follow-up after 6 month
Method of measurement
Blood test, when patient in sitting position, 5 minutes after sitting from the left arm
Intervention groups
1
Description
Control group: the content of this group included the recommendations and information in terms of change healthy lifestyle and adherence to treatment that conducted by a health center staff using a lecture and pamphlet about hypertension for six months (each session sized from 7 to 10 samples and was 30 to 45 minutes and1 session per month)
Category
Lifestyle
2
Description
Motivational interviewing group: the intervention was done through a psychologist who was authorized, each group ranged from 7 to 10 subjects that trained for 6 sessions over six months (45 to 60 minutes for each session). It focused on the behavior change of patients regarding regular physical activity, healthy dietary habits, smoking cessation, reducing stress and taking medication on time. The psychologist asked the participants to record their daily diary, adherence to medication, smoking, dietary habits, physical activity, illness perception, physical and mental health. motivational interviewing session was implemented in the health center.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Number 1 and 3 health centers located in Gorgan
Full name of responsible person
Seyyed Kamal Mirkarimi
Street address
no 19, 3rd sima alley, Vali-asr street, Gorgan city, Golestan province
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Science (Technology and Information Department)
Full name of responsible person
Seyyed Kamal Mirkarimi
Street address
kilometer 4 Gorgan- Sari road, Falsafi campus, Technology and Research Deprtment
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Science (Technology and Information Department)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Seyyed Kamal Mirkarimi
Position
Ph.D candidate
Other areas of specialty/work
Street address
no 19, 3rd sima alley, Vali-asr street
City
Gorgan
Postal code
Phone
+98 17 3253 2872
Fax
Email
k.mirkarimi@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Seyyed Kamal Mirkarimi
Position
Ph.D candidate
Other areas of specialty/work
Street address
no 19- 3rd alley- 57avenue- Gorgan- Golestan province- Iran
City
47178
Postal code
4917
Phone
+98 17 3253 2872
Fax
Email
ak.mirkarimi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Technology and Information Department of Golestan University of Medical Science
Full name of responsible person
Seyyed Kamal Mirkarimi
Position
Ph.D candidate of Health Education and Promotion Model
Other areas of specialty/work
Street address
no 19- 3rd alley- Vali-asr Street- Gorgan- Golestan province
City
Gorgan
Postal code
Phone
+98 17 3253 2872
Fax
Email
k.mirkarimi@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)