The purpose of this study is comparison the effect of two types of short message service (interactive and non-interactive) on adherence of patients with prosthetic heart valves, with emphasis on the use of anticoagulant. This is a clinical trial study. The study population are patients with prosthetic heart valves, who refer to Imam Khomeini hospital of Tehran city. Ninety eligible patients are enrolled the study and randomly divide into three groups. Self-report questionnaire is completed with patients and their International Normalized Ratio (INR) levels are recorded. The researcher gives educational leaflets to all of the patients and takes their phone number and tells them how to use the short message service. To ensure sending the messages, the researcher activated the switch "delivered" on her phone. In illiterate patients, one of their family members is requested to check the messages. For The control group does not send any message. For non-interactive group, during three months every week four educational messages are sent. Each text message is maximum 160 characters. For interactive group, in addition sending educational message, patients have two way communications with the researcher by asking their questions. During three months, each patient has at least six interactions with the researcher. After three months, all three groups again complete the Self-report questionnaire. Adherence is evaluated with questionnaire and INR levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102011177N1
Registration date:2013-06-07, 1392/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-07, 1392/03/17
Registrant information
Name
Ahmad Ali Asadi Noughabi
Name of organization / entity
Nursing and Midwifery of Tehran University Medical of Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4404
Email address
asadin@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-01-23, 1391/11/04
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two types short message service (interactive and non interactive) on adherence of patients with prosthetic heart valves
Public title
Education with short message service and adherence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have prosthetic heart valves and their surgery are at least two months ago.
Patients who take warfarin at least three months after surgery and their International Normalized Ratio (INR) must continuously be controlled.
Patients who have at least literate to read and write.
Patients who have a mobile phone at their home.
Patients who have not vision problems or have access to a third party who is able to read and write a short message for them.
Patients who have not speech, hearing and psychological problems.
The age range is between 18-65 years.
Exclusion criteria:
Changes in the medication.
Hospitalization for any reason.
Patient's reluctance to continue working.
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized method: patients are divided to three groups (control group or interactive group or non-interactive group) with lottery. First patient enters one of three groups with lottery. The second patient also enters one of the other two groups with lottery. The third patient enters remains group without lottery. Lottery continues for each patient until each group enough to reach.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Ghods St. Keshavarz Blvd. Tehran, Iran
City
Tehran
Postal code
Approval date
2013-01-14, 1391/10/25
Ethics committee reference number
2627
Health conditions studied
1
Description of health condition studied
Rheumatic heart valve diseases
ICD-10 code
I05, I06,
ICD-10 code description
Chronic rheumatic heart diseases
Primary outcomes
1
Description
Adherence to treatment
Timepoint
Before the intervention, three months after the intervention.
Method of measurement
Self-report questionnaire, INR
Secondary outcomes
empty
Intervention groups
1
Description
Control group: this group is without intervention. Patients just fill the self report questionnaire before and three months after the intervention and with measurement International Normalized Ratio (INR) before and three months after intervention, their adherences are evaluated.
Category
Prevention
2
Description
Non interactive group: for this group every week four educational messages is sent during three months by the researcher. The researcher has one way communication with the patients. Patients also, fill the self report questionnaire before and three months after the intervention and with measurement International Normalized Ratio (INR) before and three months after intervention, their adherences are evaluated.(Intervention 1)
Category
Prevention
3
Description
Interactive group: for this group every week four educational messages is sent during three months by the researcher. Researcher has interact and two-way communication with patients. Number of messages is sent by the interaction are more than the group without interaction. Patients also, fill the self report questionnaire before and three months after the intervention and with the measurement International Normalized Ratio (INR) before and three months after intervention, their adherences are evaluated. (Intervention 2)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Nadia Sedri
Street address
Keshavarz Blvd. Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research,Tehran University of Medical Sciences. Ghods St. Keshavarz Blvd. Tehran, Iran
City
Tehran
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, Tehran 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
Tehran University of Medical Science
Full name of responsible person
Nadia Sedri
Position
Master Student of Critical Care Nursing
Other areas of specialty/work
Street address
Alley 16, Resalat St. Kerman, Iran
City
Tehran
Postal code
Phone
+98 34 1321 9413
Fax
Email
nadia.sa18@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Ahmad Ali Asadi Noughabi
Position
coach
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tohid Sq. Tehran, Iran
City
Tehran
Postal code
Phone
+98 2166937120404
Fax
Email
asadi8906@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Nadia Sedri
Position
Master Student of Critical Care Nursing
Other areas of specialty/work
Street address
Alley 16, Resalat St. Kerman, Iran
City
Tehran
Postal code
Phone
+98 34 1321 9413
Fax
Email
nadia.sa18@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)