The purpose of this study is investigation effect of self-management program on medication adherence and self-efficacy in patients with mechanical heart valve. It’s a quasi-experimental study. Subjects of study will be mechanical heart valve patients hospitalized in MCCU and SCCU. In this study, 88 eligible patients with convenience sampling method (available) will be selected randomly (draw) and will be enrolled the study in both intervention and control groups. After completing demographic information, drug adherence and self-efficacy questionnaires, INR test will be controlled in both groups. control group will be received regular cares but intervention group will be participate in self-management program. this program contain two workshops, Then intervention group will be followed with telephone contacts at afternoons every week for 8 weeks. after 8 weeks drug adherence and self-efficacy questionnaires will be completed with both groups and INR test will be controlled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406154443N13
Registration date:2015-06-07, 1394/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-07, 1394/03/17
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Scinces
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation effect of self-management program on medication adherence and self-efficacy in patients with mechanical heart valve
Public title
self-management program in patients with mechanical heart valve
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The use of warfarin as an anticoagulant; The patient or the patient's immediate family members are not members of the treatment team; having 18-60 years old; Doesn’t be under another study; having heart valve replacement surgery in recent year for the first time; Doesn’t have chronic disease; Doesn’t have mental disorder. Exclusion criteria: During the study, patients had a complications of drug abuse; Wouldn’t like to continue; Wouldn’t like to continue intervention followed with telephone contacts.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
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
research deputy Tehran university of medical science
Street address
Ghods street, Keshavarz boulevard
City
Tehran
Postal code
Approval date
2014-08-23, 1393/06/01
Ethics committee reference number
130/1225/د/93
Health conditions studied
1
Description of health condition studied
mechanical heart valve patients
ICD-10 code
z95.2
ICD-10 code description
Presence of prosthetic heart valve
Primary outcomes
1
Description
drug adherence
Timepoint
before and 8 weeks after intervention
Method of measurement
drug adherence questionnaire and INR test
2
Description
self-efficacy
Timepoint
before and 8 weeks after intervention
Method of measurement
self-efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In control group just will receive regular care, without any intervention
Category
Prevention
2
Description
The intervention group, in addition to usual care, will participate in self-management program .Self-management program contains of 3 parts: medical management, role management, and emotional management, and 5 core skills of problem solving, decision making, resource utilization, the formation of the therapeutic relationship between the patient and the caregiver. workshop for 2 days and each day will be held for 4 hours and minimum of 5 and a maximum of 15 patients with mechanical heart valve will be attended in the workshop. Then the patients will be given an educational booklet. Then intervention group will be followed by telephone contacts at afternoons every week in 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Masoumeh Zakeri Moghadam
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Scinces
Full name of responsible person
Masoumeh Zakerimoghadam
Street address
Eastern Nosrat street, Tohid square
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 of Tehran University of Medical Scinces
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
Nursing- Midwifery Faculty of Tehran University of Medical Science
Full name of responsible person
Masoumeh Zakerimoghadam
Position
lecturer
Other areas of specialty/work
Street address
Nosrat street, Tohid square
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing- Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakeri Moghadam
Position
Lecturer
Other areas of specialty/work
Street address
Nosrat street, Touhid square
City
Tehran
Postal code
Phone
00
Fax
Email
zakerimo@sina.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing- Midwifery Faculty of Tehran University of Medical Science
Full name of responsible person
Masoumeh Zakerimoghadam
Position
lecturer
Other areas of specialty/work
Street address
Nosrat street, Tohid square
City
Tehran
Postal code
Phone
Fax
Email
mzakerimo@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)