The main objective of the study is to investigate the effect of smartphone applications on the quality of life and drug compliance of people with heart failure in ccu and post ccu. 2. this study as a randomized clinical trial with the control group. 3. How to do : 120 patients with heart failure that randomly divided into control and intervention groups. 4. Patients aged 18-65 years with heart failure have both class 2 and 3 heart failure shoud be approved by their physician. These people should have at least a literacy of reading, writing, and using smartphone or tablet. 5- Interventions: In the intervention group Routine treatment reception, plus the application installation on the patient's smartphone Follow-up of the program and sending motivational messages on the education of heart failure patients for 3 months. The usual care will be done to the control group in 3 months. 6- The variable is the primary outcome of quality of life and drug compliance
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061934647N1
Registration date:2017-08-20, 1396/05/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Mahboube Davoudi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 86709
Email address
davoudim3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using smartphone-based applications on medication adherence and quality of life in peopole with heart failure
Public title
The effect of using smartphone applications(software )on medication adherence and quality of life in peopole with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Having age of 18 to 65 years ؛ Patients of two groups should not be under any investigation or research؛ Having at least a reading and writing literacy ؛In 2 and 3 HF classes؛. Patients should be admitted by a physician due to an exacerbation of heart failure. ؛ Patient should has a smartphone or tablet with Android system that the application can be installed on it ؛ The ability to use the smartphone and learn how to use the application by the patient ؛ Not having any other chronic disease that requires frequent hospitalization, such as Cancer, Severe Renal Disease and Dementia؛ Gain score less than 8 from the Morrisky scale MMAS-8 (poor and moderate drug compliance) ؛ Earn more than 24 scores from" MLHFQ" (low and moderate quality of life). Exclusion criteria: Failure to use the application for one week (each patient will be log in with his own password and will be monitored) ؛Expired ؛ Hospitalization for any cause other than the illness studied, such as recent surgery
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:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran University of Medical Sciences
Street address
Iran Univercity of Medical Science, Shahid Hemmat highway, Tehran
City
Tehran
Postal code
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IUMS.FMD.REC1396.9411449003
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
150
ICD-10 code description
Heart failure
2
Description of health condition studied
Congestive heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure
3
Description of health condition studied
Left ventricular failure
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure
4
Description of health condition studied
Heart failure, unspecified
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
quality of life
Timepoint
before the intervention AND 3 month after intervention
Method of measurement
MLHFQ Scale
2
Description
medication adherence
Timepoint
before the intervention AND 3 month after intervention
Method of measurement
Morrisky Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in trial group, the application will be installed on the patient's smartphone, and then, for 3 months, patients will receive motivational messages and care messages for the management of the therapeutic and drug therapy of heart failure. Questionnaire of Minnesota‘s heart failure and Morisky Medication Adherence Scale will be completed by the two groups before and three months after the onset of the intervention.
Category
Lifestyle
2
Description
Control group :Patients will receive only current training, which includes oral explanations for illness and pamphlet, and then the Minnesota and Morrisky questionnaires will be completed before of Intervention and three months later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Mashhad
Full name of responsible person
Mahboube Davoudi Kang Sofla
Street address
Daneshgah St. , Mashhad , Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Iran University of Medical Sciences
Full name of responsible person
Seyyed Ali Javade Moosavi
Street address
Iran Univercity of Medical Science, Shahid Hemmat highway, Tehran
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 Of Research, Iran 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
School of Nursing & Midwifery of Iran University of Medical Science
Full name of responsible person
Mahboube Davoudi Kang Sofla
Position
Post Graduate Student in Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Shahid Rashid Yasemi Street, Valiasr Street, Tehran
City
Tehran
Postal code
Phone
+98 21888882886
Fax
Email
davoudim3@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing & Midwifery of Iran University of Medical Science
Full name of responsible person
Tahereh Najafi Ghezeljeh
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Shahid Rashid Yasemi St, Vali Asr St,Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
najafi.t@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing & Midwifery of Iran University of Medical Science
Full name of responsible person
Mahbobeh Davoudi kang Sofla
Position
Post Graduate Student in Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Rashid Yasemi St, Vali Asr St,Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)