Objective: To determine the effect self-management program on quality of life of elderly patients with acute coronary syndrome. Study design: Randomized. Study population: elderly patients with acute coronary syndrome. Inclusion criteria: Pleased to be working; Age over 60 years; Acute coronary syndrome is diagnosed by a doctor confirmed; Speak Farsi or Persian language to understand; Not cognitive disorders; Mental illness or severe depression that does not need to be hospitalized; There is no impairment or disability; Not blind and deaf; No event or stressful event in the past 6 months; Are living Bojnurd. Exclusion criteria: Acute diseases such as stroke during the study; Heart disease during the study or any other symptoms resulting to be hospitalized of the elderly ; To participate in the meetings; The desire to withdraw from the study; Death; Sudden stressful life events at any stage the study. Sample size: 54 patients (27 patients per group); Case study: self-management program for the intervention group; Includes five steps: Assess ;Advise; Agree; Assist; Arrange. For the first four steps are two sessions a week and to Arrange; At first phone calls daily, after two weeks, twice a week and after a month once a week until the end of the intervention period. Intervention time: 2 months; The primary outcome: the impact on quality of life.
General information
Acronym
5A- Assess ;Advise; Agree; Assist; Arrange
IRCT registration information
IRCT registration number:IRCT2016090629728N1
Registration date:2016-11-26, 1395/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Zahra Javanvash
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3231 9839
Email address
info@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2016-10-16, 1395/07/25
Expected recruitment end date
2016-12-15, 1395/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management program 5A model based on the quality of life of patients with acute coronary syndrome
Public title
The effect of self-management program on quality of life of elderly patients with acute coronary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pleased to be working; Age over 60 years; Acute coronary syndrome is diagnosed by a doctor confirmed; Speak Farsi or Persian language to understand (or be accompanied who is fluent in Farsi); Not cognitive disorders such as Alzheimer's and amnesia; Mental illness or severe depression that does not need to be hospitalized; There is no impairment or disability; Not blind and deaf; Ability to read or write is (or his retinue are literate); No event or stressful event in the past 6 months; Patients who live with their families; Are living Bojnurd exclusion criteria: Acute diseases such as stroke during the study; Heart disease during the study or any other symptoms (such as physical illness or severe depression) resulting to be hospitalized of the elderly ; To participate in the meetings; The desire to withdraw from the study; Death; Sudden stressful life events at any stage the study (death of loved -Financial problems -fire, etc).
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized allocation blocking
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee OF Sabzevar University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, University of Medical Sciences, next to the police, Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Postal code
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.MEDSAB.REC.1395.79
Health conditions studied
1
Description of health condition studied
acut coronary syndrom
ICD-10 code
I20.9-121.
ICD-10 code description
Subsequent myocardial infarction of other sites- Acute transmural myocardial infarction of other sites--Angina pectoris, unspecified Angina: NOS cardiac Anginal syndrome Ischaemic chest pain
Primary outcomes
1
Description
Quality of Life
Timepoint
Before and two months after intervention
Method of measurement
Quality of Life Questionnaire lipid
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group : self-management programs implemented in five stages; Assess stage: In this phase, using assessment form, patient risk factors, history of the patient's deterioration, heart problems, drugs, sleep, nutrition , activities and information on the records will be investigated through interviews or phone; Advise stage: At this stage, according to the results of the previous stage, abnormalities diagnosed, the patient information reaches and benefits of behavior change are emphasized, Agree stage: between patients and researchers about the function of the patient's written agreement comes the action. Thus, according to a problem has been detected for each patient, good behavior and agreed objectives determined for each of the objectives, action plan design. For each behavioral objectives measure between 0 to 10 specific the patient's degree of confidence in the program set; Assist stage: Education, such as taking blood pressure, Pulse control, Glucose control, face-to-face and the patient is asked to do these exercises daily and record their performance; Arrange stage: The stage performance will be followed patients for two months.
Category
Behavior
2
Description
Control group : only the medical care provided by specialists use.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Maryam Mojdekanloo
Street address
Imam Reza Hospital, Street Sayed Jamaluddin Asadabadi, Bojnurd, North Khorasan, Iran
City
Bojnurd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Sabzevar University of Medical Sciences
Full name of responsible person
Musa al-Reza Tadayonfar
Street address
School of Nursing and Midwifery, Sabzevar University of Medical Sciences
City
Sabzevar
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, Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Javanvash
Position
Elderly Nursing Graduate Student
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, next to the police, Sabzevar,Razavi Khorasan , Iran
City
Sabzevar
Postal code
Phone
+98 58 3231 9839
Fax
Email
javanvashZ93@medsab.ac.ir; javanvashz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
MostfaRad
Position
PhD
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, next to the police, Sabzevar,Rasavi Khorasan, Iran
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
mostafarad633@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Javanvash
Position
Elderly Nursing Graduate Student
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, next to the police, Sabzevar, Rasavi Khorasan, Iran
City
Sabzevar
Postal code
Phone
+98 58 3231 9839
Fax
Email
javanvashZ93@medsab.ac.ir; javanvashz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)