Heart Attack PatientsNCT06951958
Application of the Health Action Process Approach Model Program to Patients With Heart Attacks
A study testing Cardiac Rehabilitation Program Based on Health Action Process Approach Model in people with Heart Attack Patients, run by TC Erciyes University.
Trial summary
This research is conducted to determine whether the nurse-led Health Action Process Approach Model-based Cardiac Rehabilitation Program is effective in patients with myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Attack Patients
- What is being tested?
- Cardiac Rehabilitation Program Based on Health Action Process Approach Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between 18-70 years old,
- Becoming literate,
- Living in the city center
- Having had a heart attack within the last month,
- Not having had a heart attack before,
- Dyspnea less than 4-5 degrees according to the modified Borg Scale
- No deformity or diagnosis related to the musculoskeletal system that may prevent physical activity, no orthopedic limitation
- Stable New York Heart Association (NHYA) functional class I or II coronary artery disease with myocardial infarction
Who cannot join
- Those with communication disabilities such as speech, vision, hearing
- Dyspnea score of more than 4-5 degrees according to the modified Borg Scale
- Those who stayed in intensive care for a long time after MI
- Complications related to treatment and interventions after MI
- Those who underwent surgical treatment after MI,
- Those with chronic diseases (chronic obstructive pulmonary disease, chronic renal failure, hypertension, diabetes, pulmonary emphysema, rheumatic valve disease, cancer diagnosis, etc.)
- Those who indicated that they would not participate in intervention programs due to time constraints.
- Failure of the six-minute walk test
About this study
Official title: The Effect of Cardiac Rehabilitation Program Based on Health Action Process Approach Model on Treatment Compliance, Quality of Life and Functional Capacity Level in Individuals With Myocardial Infarction
This research is conducted to determine whether the nurse-led Health Action Process Approach Model-based Cardiac Rehabilitation Program is effective in patients with myocardial infarction. The population of the study will consist of coronary angiography patients with myocardial infarction in the cardiology service of a state hospital. In this study, which is planned as a randomized controlled experimental model, 35 intervention and 35 control groups will be studied. As data collection tools; patient identification form, Laboratory Investigations Monitoring Form, Perceived Stress Scale, Health Action Process Approach Based Participant Assessment Form, Health Action Process Approach Based Myocardial Infarction Risk Factors Participant Assessment Form Functional Capacity Assessment Form, Myocardial Infarction Dimensional Assessment Scale and Turkish Modified Morisky Scale will be used. Health Action Process Approach Modeled Cardiac Rehabilitation Program will be applied to the intervention group and no intervention will be applied to the control group. Data will be collected with data collection tools at 6, 12, 24 weeks. SPSS 25.0 (Stastical Package for Social Science) package program will be used for statistical analysis of the data. Descriptive statistics will be given as number, percentage, mean, standard deviation and median values. The normal distribution of the data of numerical variables will be evaluated by Shapiro Wilk test. Two group comparisons will be made with independent two sample t-test for normally distributed variables and with Mann-Whitney U test for variables that do not show normal distribution. Comparisons of the groups' pre-test, week 6, week 18 and week 24 scale scores will be made with two-way analysis of variance in repeated measures from general linear models.
- Conditions
- Heart Attack Patients
- Being tested
- Cardiac Rehabilitation Program Based on Health Action Process Approach Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation Program Based on Health Action Process Approach ModelBehavioural
The intervention program will start in the hospital setting and continue at home. A work schedule will be created with each individual in intervention group 1 by determining the times when they are available separately. Individuals are planned to receive 60-minute home visits once a week. In the following weeks, care interventions such as home visits, training, counseling and monitoring will be organized according to the specific needs and requirements of each individual. In the face-to-face preparation phase, the patient's health needs will be identified, health status will be assessed, daily activities will be reviewed, incompatibility between activity levels and recommended exercise guidelines will be examined, and individualized exercise goals and a behavior-specific exercise program will be created for behavioral changes. In the intervention phase, the parts that the patient lacks will be determined and the trainings needed will be given.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Behavioral Interventions will be provided to the intervention group using the Cardiac Rehabilitation Program based on the Health Action Process Approach Model. Receives: Behavioral: Cardiac Rehabilitation Program Based on Health Action Process Approach Model |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in treatment compliance of people participating in the Health Action Process Approach Model-based Cardiac Rehabilitation Program
It was developed by Morisky et al. in 1986. It is a 6-item scale used to measure medication compliance in patients.
Measured: At the beginning of the study (week 0), week 6, week 12 and week 24
Secondary outcomes (1)
Changes in the Quality of Life of People Participating in a Cardiac Rehabilitation Program Based on the Health Action Process Approach Model
Developed in 2002 by Thompson et al, this scale is specific for patients with myocardial infarction. It is a 35-item scale used to measure quality of life in patients.
Measured: At the beginning of the study (week 0), week 6, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start20 May 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Attack PatientsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gönül Taşcı, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951958
- Sponsor's protocol ID
- GTasci
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardiac Rehabilitation Program Based on Health Action Process Approach Model on Treatment Compliance, Quality of Life and Functional Capacity Level in Individuals With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06951958
- Acronym / sponsor ID
- GTasci
- Conditions
- Heart Attack Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 30 Apr 2025 (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.
This research is conducted to determine whether the nurse-led Health Action Process Approach Model-based Cardiac Rehabilitation Program is effective in patients with myocardial infarction. The population of the study will consist of coronary angiography patients with myocardial infarction in the cardiology service of a state hospital. In this study, which is planned as a randomized controlled experimental model, 35 intervention and 35 control groups will be studied. As data collection tools; patient identification form, Laboratory Investigations Monitoring Form, Perceived Stress Scale, Health Action Process Approach Based Participant Assessment Form, Health Action Process Approach Based Myocardial Infarction Risk Factors Participant Assessment Form Functional Capacity Assessment Form, Myocardial Infarction Dimensional Assessment Scale and Turkish Modified Morisky Scale will be used. Health Action Process Approach Modeled Cardiac Rehabilitation Program will be applied to the intervention group and no intervention will be applied to the control group. Data will be collected with data collection tools at 6, 12, 24 weeks. SPSS 25.0 (Stastical Package for Social Science) package program will be used for statistical analysis of the data. Descriptive statistics will be given as number, percentage, mean, standard deviation and median values. The normal distribution of the data of numerical variables will be evaluated by Shapiro Wilk test. Two group comparisons will be made with independent two sample t-test for normally distributed variables and with Mann-Whitney U test for variables that do not show normal distribution. Comparisons of the groups' pre-test, week 6, week 18 and week 24 scale scores will be made with two-way analysis of variance in repeated measures from general linear models.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cardiac Rehabilitation Program Based on Health Action Process Approach ModelBehavioral Interventions will be provided to the intervention group using the Cardiac Rehabilitation Program based on the Health Action Process Approach Model. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be between 18-70 years old,
- Becoming literate,
- Living in the city center
- Having had a heart attack within the last month,
- Not having had a heart attack before,
Key exclusion criteria (8 listed)
- Those with communication disabilities such as speech, vision, hearing
- Dyspnea score of more than 4-5 degrees according to the modified Borg Scale
- Those who stayed in intensive care for a long time after MI
- Complications related to treatment and interventions after MI
- Those who underwent surgical treatment after MI,
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 |
|---|---|---|
| Cardiac Rehabilitation Program Based on Health Action Process Approach ModelThe intervention program will start in the hospital setting and continue at home. A work schedule will be created with each individual in intervention group 1 by determining the times when they are available separately. Individuals are planned to receive 60-minute home visits once a week. In the following weeks, care interventions such as home visits, training, counseling and monitoring will be organized according to the specific needs and requirements of each individual. In the face-to-face preparation phase, the patient's health needs will be identified, health status will be assessed, daily activities will be reviewed, incompatibility between activity levels and recommended exercise guidelines will be examined, and individualized exercise goals and a behavior-specific exercise program will be created for behavioral changes. In the intervention phase, the parts that the patient lacks will be determined and the trainings needed will be given. | Behavioural | Intervention group |
Primary outcome
Changes in treatment compliance of people participating in the Health Action Process Approach Model-based Cardiac Rehabilitation Program
Time frame: At the beginning of the study (week 0), week 6, week 12 and week 24
It was developed by Morisky et al. in 1986. It is a 6-item scale used to measure medication compliance in patients.
1 secondary outcome
Changes in the Quality of Life of People Participating in a Cardiac Rehabilitation Program Based on the Health Action Process Approach Model
Time frame: At the beginning of the study (week 0), week 6, week 12 and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation Program Based on Health Action Process Approach Model in people with Heart Attack Patients, run by TC Erciyes 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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in treatment compliance of people participating in the Health Action Process Approach Model-based Cardiac Rehabilitation Program (time frame: At the beginning of the study (week 0), week 6, week 12 and week 24). 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 30 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.