Evaluating the effect of the Continuous Care Model on the self-management of a sample of Iranian post-myocardial infarction patients: A randomized controlled trial
This study aims to investigate the effects of applying the Continuous Care Model on self-management of a sample of Iranian post-myocardial infarction patients. After selecting 70 patients using convenience sampling, they will be allocated into control (n=35) and intervention (n=35) groups using block randomization method. Before the intervention and the end of it, self-management of both groups will be evaluated using Chronic Disease Self-management Questionnaire. The Continuous Care Model will be performed for the intervention group for three months. Inclusion criteria: age between 18 and 75 years; a minimum literacy level of primary school; access to telephone; MI for the first time with no previous history of cardiovascular surgery or percutaneous coronary intervention; lack of mobility-limiting conditions, sustained arrhythmias, or a disease inhibiting self-care. Exclusion criteria: occurrence of any condition contradictory with inclusion criteria (for example, undergoing a cardiovascular surgery during the period of the study); employment of close relatives of the patient or the patient him/herself in healthcare organizations
General information
Acronym
Continuous Care Model (CCM)
myocardial infarction (MI)
IRCT registration information
IRCT registration number:IRCT2016051021549N2
Registration date:2016-06-28, 1395/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-28, 1395/04/08
Registrant information
Name
Omolbanin Akbari
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3244 3041
Email address
omolbaninakbari@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-03, 1395/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of the Continuous Care Model on the self-management of a sample of Iranian post-myocardial infarction patients: A randomized controlled trial
Public title
Effect of the Continuous Care Model on self-management of post-myocardial infarction patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 75 years; a minimum literacy level of primary school; access to telephone; MI for the first time with no previous history of cardiovascular surgery or percutaneous coronary intervention; lack of mobility-limiting conditions, sustained arrhythmias, or a disease inhibiting self-care.
Exclusion criteria: occurrence of any condition contradictory with inclusion criteria (for example, undergoing a cardiovascular surgery during the period of the study); employment of close relatives of the patient or the patient him/herself in healthcare organizations
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
Approval date
2014-07-05, 1393/04/14
Ethics committee reference number
Ir.bums.1393.06
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
Acute Myocardial Infarction
Primary outcomes
1
Description
Self-management
Timepoint
Before and 3 months after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the intervention will be as follows: Upon introduction of the study and statement of the purposes, the patients will provide informed consents and complete the demographics form and Chronic Disease Self-management Scale. Then, the Continuous Care Model will be presented to the participants in the intervention group for three months. The Continuous Care Model consists of four stages: (1) orientation, (2) sensitization, (3) control, and (4) evaluation. At the end of three months, Chronic Disease Self-management Scale will be completed.
Category
Other
2
Description
The control group will be treated as follows: Upon introduction of the study and statement of the purposes, the patients will provide informed consents and complete the demographics form and Chronic Disease Self-management Scale. Then, they will receive the routine care for three months. At the end of three months and under similar circumstances with the intervention group, Chronic Disease Self-management Scale will be completed by them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-asr Hospital
Full name of responsible person
Omolbanin Akbari
Street address
Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Deputy of Reserach, Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Omolbanin Akbari
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences; Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 2001
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Omolbanin Akbari
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 2001
Fax
Email
omolbaninakbari@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Omolbanin Akbari
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Ghaffari St.
City
Birjand
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)