The purpose of this study is to diagnose effect of multifaceted intervention on blood pressure control and drug compliance among uncontrolled hypertension patients.
Design
A controlled clinical trial was randomly conducted on 72 patients in Emergency of Alzahra hospital, Isfahan University of Medical Sciences from April to June 2018.
Settings and conduct
Subsequent to consent form, samples were randomly divided into intervention and control groups. Multifaceted intervention includes: encouragement interviews and a four-week training (90 minutes per session), a drug reminder box, family support and 4 phone follow ups. Morisky Questionnaire was used before and one month after the intervention. Blood pressure was measured in both groups at baseline and one month later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least one year background of hypertension with doctor approval؛ Under hypertension medical therapy؛ Recorded hypertension higher than 140/190 mmHg at the time of emergency reception.
Intervention groups
intervention and control groups
Main outcome variables
Multifaceted intervention promoted drug compliance and reduced systolic and diastolic blood pressure. Thus patients are recommended to use it as a supplement after their discharge.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110821007391N6
Registration date:2018-10-19, 1397/07/27
Registration timing:retrospective
Last update:2018-10-19, 1397/07/27
Update count:0
Registration date
2018-10-19, 1397/07/27
Registrant information
Name
Maryam Eghbali Babadi
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7539
Email address
eghbali@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2018-04-19, 1397/01/30
Trial completion date
2018-06-20, 1397/03/30
Scientific title
Investigating Effect of a Multifaceted Intervention on Blood Pressure Control and Drug Compliance in Patients with Uncontrolled Hypertension
Public title
Effect of a Multifaceted Intervention on Blood Pressure Control and Drug Compliance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year background of hypertension with doctor approval
Under hypertension medical therapy
Recorded hypertension higher than 140/190 mm Hg at the time of emergency reception
Accompaniment of one family member
Not having a background of Alzheimer's disease
Exclusion criteria:
Development of serious problems, life threatening or any disability or death, for the study sample during the study
Dissatisfaction or withdrawal from the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Envelopes containing cards with numbers one and two were given to participants, in the case of selecting the number one, depending on the intervention and the choice of the number two, they were placed in the control group
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 Isfahan University of Medical Sciences
Street address
Hezar-Jerib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-02-19, 1396/11/30
Ethics committee reference number
IR.MUI.REC 1396.3.841
Health conditions studied
1
Description of health condition studied
Essential (primary) hypertension
ICD-10 code
ICD-I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before and after education
Method of measurement
Blood Pressure measurement device
2
Description
adherence to drug therapy
Timepoint
Before and after education
Method of measurement
Morisky medication adherence questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For intervention group, 10-member groups with family member, an encouragement interview along with delivering a seven-part medication reminder box for one week medication. Then three training sessions (90 minutes) was held in 3 weeks and emphasis was placed on family support for medication. Also, four telephone contacts with study samples and a family member were made at the end of each week for 10 minutes by appointment. Training sessions were relevant to nature and side-effects of diseases and the consequences of not taking hypertension medication, methods of controlling the disease via appropriate lifestyle .Other approached included presenting information through lectures, Power Points, discussion between participants, and training booklet. Additionally, the content of phone contact was Q & A sessions regarding reinforcement of contents, strengthening family support technique and utilization of medication reminder box finalizing with uncovering potential problems of study samples.
Category
Lifestyle
2
Description
Control group: Before and a month later, control group participants were invited for data collection. In the meantime, in order that ethical codes are followed, study samples in the control group were given a drug reminder box and a training booklet with regard to discussions on the training sessions.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency of Al-Zahra Hospital
Full name of responsible person
Azam alsadat Mirniam
Street address
Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7597
Email
mirniam2013@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Eghbali Babadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Hezar Jerib Avenue
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7597
Email
eghbali@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Eghbali Babadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7539
Email
eghbali@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Eghbali Babadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7597
Email
eghbali@nm.mui.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