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

NCT03771937 | Completed DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Infarction

Keywords

lifestyle change; telephone follow-up; Roy Adaptation Model

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

the control group received routine care.

Interventions

Education and telephone follow-up intervention OTHER

A telephone follow up and a pre-discharge education

Intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Selma Turan Kavradım, PhD

  Akdeniz University Nursing Faculty

  PRINCIPAL INVESTIGATOR

• Zeynep Canlı ÖZER, Professor

  Akdeniz University Nursing Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding was provided that included inclusion criteria and agreement to participate in the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Faculty

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 11, 2018
• Study Start: April 3, 2016
• Primary Completion: August 25, 2017
• Study Completion: September 25, 2017
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share