The aim of this study was to evaluate the effect of collaborative care on the quality of life of patients after coronary angioplasty.
The present study is a two-group two-stage of before and after clinical trial. In this study samples were selected randomly by simple sampling and divided into two groups of intervention (25 participants) and control (25 participants). Collaborative care model was executed in the intervention group for 3 months. The inclusion criteria were being aged more than 18 and less than 70 years, having appropriate clinical condition according to physician’s diagnosis and not having any constraints for performing the interventions. Also if the patient of the intervention group was absent for more than 2 educational sessions, die or encounter any problem that would make them unable to continue the study, they were excluded. In the intervention group, collaborative treatment program was conducted in 5 sessions and for the control group, two sessions were conducted to discuss the importance of medication, diet and exercise. Data was gathered before and 3 months after the intervention using demographic characteristics and quality of life (SF-36) questionnaires.
General information
Acronym
_
IRCT registration information
IRCT registration number:IRCT2015120120912N4
Registration date:2016-03-03, 1394/12/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-03, 1394/12/13
Registrant information
Name
Mohsen Shahriari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2915
Email address
shahriari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of collaborative care on the quality of life of patients after coronary angioplasty
Public title
The effect of cooperation of treatment team and the patient on the quality of life in patients after coronary angioplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being aged more than 18 and less than 70 years; being conscious; having the ability to make communication; being aware of their disease; being able to read and write; not having an acute cardiovascular disease, diabetes type 1 and 2, hormone disorders and renal and mental diseases; having appropriate clinical condition according to physician’s diagnosis and not having any constraints for performing the interventions.
Exclusion criteria: being absent for more than 2 educational sessions for intervention group; die or encounter any problem that would make them unable to continue the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjrib Ave, Isfahan
City
Isfahan
Postal code
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
394174
Health conditions studied
1
Description of health condition studied
patients after coronary angioplasty
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft
Primary outcomes
1
Description
quality of life
Timepoint
Before the intervention and 3 month after intervention
Method of measurement
SF-36 questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: collaborative treatment program was conducted in 5 group sessions; in a way that 3 educational collaborative care sessions were conducted weekly and 2 collaborative care follow-up sessions were conducted every other week and each session was 45 to 60 minutes. At first, the educational content was prepared by the researcher nurse based on authentic texts and original sources and in a collaborative session in the presence of the expert physician and the participants, the educational content was represented and the collaborative program was finalized after each participant’s agreement. During the session speech, question and answer and groups and individual discussion were used. After conducting the collaborative program, follow-up was conducted by calling the participants and addressing their questions and problems, as it has been agreed on before. During the first session patients were introduced to their current disease and its threats and complications and appropriate diet and physical activity and the right method of drug consumption for patients with coronary artery disease was explained to them by an expert physician and a nurse through a speech. During the second session, the presented educational content was discussed between the physician and the nurse with participation of the patients and an agreement was reached about the appropriate diet and physical activities and the final program was executed by patients’ opinion. During the third session the presented educational program was discussed between the physician, the nurse and the patients and an agreement was reached about the right method of drug consumption and the final program was executed by patients’ opinion. The collaborative care follow-up sessions were conducted for continuity of the care program and involvement of the patients. Sessions were conducted every other week and twice for each patient. After the collaborative follow-up sessions, patients were followed up for 12 weeks through phone calls and by addressing their questions and problems, as it has been agreed on before.
Category
Other
2
Description
Control group: two group sessions were conducted to discuss the importance of medication, diet and exercise. sessions were held weekly each lasting 60 minutes.