The effect of follow up using short message service on illness perception and medication adherence in patients under coronary angioplasty: a one blind randomized control trial
This study is a randomized clinical trial with a two-armed parallel design with the aim to survey the impact of SMS-based follow-up on illness perception and medication adherence among the patients with acute coronary syndrome after percutaneous coronary angioplasty. First of all, after receiving the approval of Research Ethics Committee of Tabriz University of Medical Sciences, the researcher will go to specialized cardiology clinics of Tabriz University of Medical Sciences to access to the research units. The patients with acute coronary syndrome who have passed one month after angioplasty are to be selected according to the convenient method and their consensus to participate the study will be achieved. The sample size for the study will be 116 randomly selected patients and will be classified in two groups of Control and Experimental. The questionnaire considering the perception of the disease and the adherence to medication will be completed by the participants in two groups. Then, using the short message system, the follow-up SMSs including 160 character, will be sent to every individual patient in each intervention group for a period of 3 months at the specified intervals (five times a week at 10 o’clock in the morning except Thursdays and Fridays). The patients in Control group will receive a routine follow-up.At the end of intervention, the perception of the disease and the adherence to medication will be compared in two groups using the BIPQ (Brief Illness Perception Questionnaire) and MMAS (Morisky Medication Adherence Scale) respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011025937N1
Registration date:2016-02-20, 1394/12/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-20, 1394/12/01
Registrant information
Name
Aefeh Allahbakhshian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
allahbakhshiana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of follow up using short message service on illness perception and medication adherence in patients under coronary angioplasty: a one blind randomized control trial
Public title
The effect of follow up using short message service on illness perception and medication adherence in patients under coronary angioplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in range of 18 to 65 years old with diagnosis of acute coronary syndrome referred to Cardiac Clinic of Tabriz University of Medical Sciences; Patients who have gone under angioplasty for at least one month before the study; With the ability to read SMSs; Samples are selected by own tendency; Have a mobile phone and have the ability to use it; Not participating in a similar study like the current one;
Exclusion criteria:
Not willing to participate in the study; Not having a mobile phone; Referrals to other treatment centers during the study; Not able to read the SMSs; not being accessible after 12 weeks (eg. travelling aboard); Having cognitive impairment, based on patients records
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
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
Ethics Commitee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht ave., Tabriz, Iran
City
Tabriz
Postal code
5165665931
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
TBZMED.REC.1394.869
Health conditions studied
1
Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I25.8
ICD-10 code description
Other forms of chronic ischaemic heart disease
Primary outcomes
1
Description
Illness perception
Timepoint
Before the beginning of intervention and soon as the end of intervention at the end of the third month
Method of measurement
Brief illness perception questionaire
2
Description
Medication adherence
Timepoint
Before the beginning of intervention and soon as the end of intervention at the end of the third month
Method of measurement
Morisky medication adherence questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Sending follow-up SMSs for the patients after angioplasty, containing educational subjects, reminders regarding refer time and drug use (five times a week at 10 o’clock in the morning except Thursdays and Fridays) for 3 months to the intervention group.
Category
Other
2
Description
routine follow up for control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Atefeh Allahbakhshian
Street address
South Shariaty ave., Faculty of Nursing and Midwifery
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
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 (VCR) of Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Atefeh Allahbakhshian
Position
PhD of nursing education
Other areas of specialty/work
Street address
South Shariaty ave, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
allahbakhshiana@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr atefeh allahbakhshian
Position
PhD of nursing education
Other areas of specialty/work
Street address
South Shariaty ave, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
allahbakhshiana@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Atefeh Allahbakhshian
Position
PhD of nursing education
Other areas of specialty/work
Street address
South Shariaty ave., Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
allahbakhshiana@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)