Myocardial InfarctionNCT03771937
The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model
A study testing Education and telephone follow-up intervention in people with Myocardial Infarction, run by Akdeniz University.
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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Education and telephone follow-up intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 3 Apr 2016to 25 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Education and telephone follow-up intervention
- Keywords
- lifestyle change, telephone follow-up, Roy Adaptation Model
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and telephone follow-up interventionOther
A telephone follow up and a pre-discharge education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Education and telephone follow-up intervention |
| Control group | No intervention | the control group received routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start3 Apr 2016
- Primary completion25 Aug 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Turan, Akdeniz University
- Investigators
- Selma Turan Kavradım, PhD, Principal investigator, Akdeniz University Nursing FacultyZeynep Canlı ÖZER, Professor, Study director, Akdeniz University Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771937
- Sponsor's protocol ID
- 0001
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2018
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators plan to send the results to an international journal and all results can be obtained after publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model After Myocardial Infarction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03771937
- Acronym / sponsor ID
- 0001
- Conditions
- Myocardial Infarction
- Keywords
- lifestyle change, telephone follow-up, Roy Adaptation Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 3 Apr 2016 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Education and telephone follow-up interventionIntervention 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. |
| Control group | No intervention | –the control group received routine care. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and telephone follow-up interventionA telephone follow up and a pre-discharge education | Other | Intervention |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No. The investigators plan to send the results to an international journal and all results can be obtained after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selma Turan Kavradım, PhD principal investigator
Akdeniz University Nursing Faculty
Zeynep Canlı ÖZER, Professor study director
Akdeniz University Nursing Faculty
Questions about this trial
What is this clinical trial studying?
A study testing Education and telephone follow-up intervention in people with Myocardial Infarction, run by Akdeniz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Self-Efficacy Scale (time frame: 12 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.