The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model

Sponsor

Akdeniz University (Other)

Overall Status

Completed

CT.gov ID

NCT03771937

Collaborator

(none)

Enrollment

Arms

17.7

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Other: Education and telephone follow-up intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Single blinding was provided that included inclusion criteria and agreement to participate in the study

Primary Purpose:

Prevention

Official Title:

The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model After Myocardial Infarction: a Randomized Controlled Trial

Actual Study Start Date :

Apr 3, 2016

Actual Primary Completion Date :

Aug 25, 2017

Actual Study Completion Date :

Sep 25, 2017

Arms and Interventions

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.	Other: Education and telephone follow-up intervention A telephone follow up and a pre-discharge education
No Intervention: Control group the control group received routine care.

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.

Other: Education and telephone follow-up intervention

A telephone follow up and a pre-discharge education

No Intervention: Control group

the control group received routine care.

Outcome Measures

Primary Outcome Measures

General Self-Efficacy Scale [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.
Coping and Adaptation scale [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.
Myocardial Infarction Dimensional Assessment Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Akdeniz University

Investigators

Principal Investigator: Selma Turan Kavradım, PhD, Akdeniz University Nursing Faculty
Study Director: Zeynep Canlı ÖZER, Professor, Akdeniz University Nursing Faculty