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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: Education and telephone follow-up intervention

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: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 week
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
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

Collaborators and Investigators

• Sponsor: Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2016
• Primary Completion (Actual): August 25, 2017
• Study Completion (Actual): September 25, 2017

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: lifestyle change; telephone follow-up; Roy Adaptation Model
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 0001 (Researcher)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators plan to send the results to an international journal and all results can be obtained after publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No