- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03771937
The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model
The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model After Myocardial Infarction: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
|
A telephone follow up and a pre-discharge education
|
No Intervention: Control group
the control group received routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Self-Efficacy Scale
Time Frame: 12 week
|
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.
|
12 week
|
Coping and Adaptation scale
Time Frame: 12 week
|
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.
|
12 week
|
Myocardial Infarction Dimensional Assessment Scale
Time Frame: 12 week
|
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.
|
12 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001 (Cancer Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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