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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03771937
Other study ID # 0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2016
Est. completion date September 25, 2017

Study information

Verified date March 2023
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date September 25, 2017
Est. primary completion date August 25, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: 1. 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). 2. were clinically stable 3. willing to participate 4. able to understand and write Turkish 5. able to receive telephone calls or fill in questionnaires. 6. 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Education and telephone follow-up intervention
A telephone follow up and a pre-discharge education

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 a 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
Primary 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. 12 week
Primary 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. 12 week
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