Back to resultsThe Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education and telephone follow-up intervention
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Infarction focused on measuring lifestyle change, telephone follow-up, Roy Adaptation Model
Eligibility Criteria
Inclusion Criteria:
- Participants were adults aged ≥30 years and had been admitted to the hospital with a diagnosis of MI (which must be supported by ECG and an increase in biomarkers).
- were clinically stable
- willing to participate
- able to understand and write Turkish
- able to receive telephone calls or fill in questionnaires.
- able to come to the hospital for checkups. Exclusion Criteria:Patients were excluded from the study if according to medical file records they had chronic renal failure, cancer, heart failure, severe aortic stenosis, if they were planned for surgical treatment or had chronic cognitive and psychiatric disease, if they had problems with hearing and speaking on the phone, or if they had mobility restriction.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control group
Arm Description
Intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the RAM.
the control group received routine care.
Outcomes
Primary Outcome Measures
General Self-Efficacy Scale
The self-efficacy levels of the patients were measured by the General Self-Efficacy Scale (GSES). The GSES contains 10 items and each item score ranges from 0 to 5. Cronbach's α of the GSES was 0.83. The highest and lowest possible score is between 10-40. High score indicates that the individual perceives high self-efficacy.
Coping and Adaptation scale
To evaluate the coping and adaptation processes, the Coping and Adaptation (CAPS) scale was used. The CAPS was developed by Callista Roy. The Turkish validity and reliability study of the scale was conducted by Çatal and Dicle (2015), and the Cronbach alpha value was 0.82 for the total scale. The highest and lowest possible score is between 47-188. Higher scores indicate better use of effective coping methods.
Myocardial Infarction Dimensional Assessment Scale
To evaluate the quality of life after the disease, the Myocardial Infarction Dimensional Assessment Scale (MIDAS) was used. This was developed by Thompson et al. in 2002. The Cronbach alpha values of the scale were found in seven dimensions, and ranged from 0.74 to 0.95, showing it to be a useful and highly reliable tool. The validity and reliability study of the scale was made by Yilmaz et al. Cronbach alpha values ranged from 0.79 to 0.90. The 10 highest and lowest possible score is between 0-100, with 0 indicating the best health condition, and 100 indicating the worst health condition.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771937
Brief Title
The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model
Official Title
The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model After Myocardial Infarction: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2016 (Actual)
Primary Completion Date
August 25, 2017 (Actual)
Study Completion Date
September 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this parallel randomized controlled trial (n = 33/group), the control group received routine care, while the intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the Roy Adaptation Model.
Detailed Description
Objective: To evaluate the effect of education and telephone follow-up intervention based on the Roy Adaptation Model (RAM) for improving MI patients' self-efficacy, quality of life and lifestyle adaptation.
Methods: In this parallel randomized controlled trial (n = 33/group), the control group received routine care, while the intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the RAM. Data were collected before discharge, and in the 12th week after discharge included quality of life, coping adaptation process, self-efficacy and lifestyle changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
lifestyle change, telephone follow-up, Roy Adaptation Model
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blinding was provided that included inclusion criteria and agreement to participate in the study
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the RAM.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
the control group received routine care.
Intervention Type
Other
Intervention Name(s)
Education and telephone follow-up intervention
Intervention Description
A telephone follow up and a pre-discharge education
Primary Outcome Measure Information:
Title
General Self-Efficacy Scale
Description
The self-efficacy levels of the patients were measured by the General Self-Efficacy Scale (GSES). The GSES contains 10 items and each item score ranges from 0 to 5. Cronbach's α of the GSES was 0.83. The highest and lowest possible score is between 10-40. High score indicates that the individual perceives high self-efficacy.
Time Frame
12 week
Title
Coping and Adaptation scale
Description
To evaluate the coping and adaptation processes, the Coping and Adaptation (CAPS) scale was used. The CAPS was developed by Callista Roy. The Turkish validity and reliability study of the scale was conducted by Çatal and Dicle (2015), and the Cronbach alpha value was 0.82 for the total scale. The highest and lowest possible score is between 47-188. Higher scores indicate better use of effective coping methods.
Time Frame
12 week
Title
Myocardial Infarction Dimensional Assessment Scale
Description
To evaluate the quality of life after the disease, the Myocardial Infarction Dimensional Assessment Scale (MIDAS) was used. This was developed by Thompson et al. in 2002. The Cronbach alpha values of the scale were found in seven dimensions, and ranged from 0.74 to 0.95, showing it to be a useful and highly reliable tool. The validity and reliability study of the scale was made by Yilmaz et al. Cronbach alpha values ranged from 0.79 to 0.90. The 10 highest and lowest possible score is between 0-100, with 0 indicating the best health condition, and 100 indicating the worst health condition.
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants were adults aged ≥30 years and had been admitted to the hospital with a diagnosis of MI (which must be supported by ECG and an increase in biomarkers).
were clinically stable
willing to participate
able to understand and write Turkish
able to receive telephone calls or fill in questionnaires.
able to come to the hospital for checkups. Exclusion Criteria:Patients were excluded from the study if according to medical file records they had chronic renal failure, cancer, heart failure, severe aortic stenosis, if they were planned for surgical treatment or had chronic cognitive and psychiatric disease, if they had problems with hearing and speaking on the phone, or if they had mobility restriction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selma Turan Kavradım, PhD
Organizational Affiliation
Akdeniz University Nursing Faculty
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeynep Canlı ÖZER, Professor
Organizational Affiliation
Akdeniz University Nursing Faculty
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The investigators plan to send the results to an international journal and all results can be obtained after publication.
Learn more about this trial
The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model
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