Heart FailureNCT06074887
The Effect of Model-based Cardiac Rehabilitation on Self-care, Quality of Life, and Self-efficacy in Patients With Heart Failure
A study testing transtheoretical model-based intervention in people with Heart Failure, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The main reason why heart failure (HF) is an important public health problem is that the incidence of HF is increasing and mortality rates remain unchanged despite the decline in the incidence of coronary artery disease. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- transtheoretical model-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 15 Dec 2024
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unable to participate regularly in the intervention/follow-up Currently enrolled in an active cardiac rehabilitation program Contraindications for cardiac rehabilitation Hypertrophic heart failure Advanced aortic stenosis Angina pectoris Oncological diagnosis Advanced COPD Dialysis treatment Myocardial infarction within the last 6 months Pregnancy Morbid obesity Cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Nurse-led, Transtheoretical Model-based Home Education and Follow-up Programme on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial
The main reason why heart failure (HF) is an important public health problem is that the incidence of HF is increasing and mortality rates remain unchanged despite the decline in the incidence of coronary artery disease. The ageing population and improved medical care services are the main factors supporting this increase. In the guidelines, education and rehabilitation are recommended for symptomatic HF patients with the highest level of evidence and recommendation (Class 1A) and considered as an integral part of HF treatment. The aim of this study was to investigate the effect of Transtheoretical Model-based cardiac rehabilitation training on self-care, quality of life and self-efficacy levels of HF patients. The study was conducted with a parallel-group, randomised controlled experimental design with pre-test and post-test measurements. Thirty-two experimental and 31 control patients, randomly assigned according to inclusion and exclusion criteria, were followed up at home for 12 weeks. Transtheoretical Model (TTM)-based CR training was applied to the intervention group through home visits. Data were collected through socio-demographic information form, behaviour change stage diagnostic form, Minnesota Living with Heart Failure Scale, European Heart Failure Self-Care Behaviour Scale, General Self-Efficacy Scale, home visit follow-up chart, patient follow-up form, telephone counselling follow-up chart and general condition assessment form. Number, percentage, mean and standard deviation were used for descriptive statistics; independent and dependent sample t-test, repeated measures ANOVA test, Chi-Square test, Fisher's Exact test, Fisher-Freeman-Halton Exact test, Wilcoxon Signed Ranks test, Mann-Whitney U test and Friedman test were used for comparative analyses. The findings showed that the TTM-based KR programme had a statistically significant effect on increasing the quality of life, self-efficacy and self-care levels and improving the clinical parameters of the patients in the intervention group. Improvement was observed in the NYHA classification of the patients in the intervention group and 96.9% of them were determined to have passed to the 'movement' stage of TTM. It is recommended that home-based CR programmes should be disseminated and health professionals should be trained in TTM-based interventions to improve the general condition and clinical parameters of HF patients. It is also recommended to investigate the effectiveness of TTM-based training programmes in different patient groups and to evaluate their long-term effects.
Read the detailed description
A total of 74 participants were randomized, and 63 participants completed the 12-week follow-up.
- Conditions
- Heart Failure
- Being tested
- transtheoretical model-based intervention
- Keywords
- Transtheoretical Model, Cardiac Rehabilitation, Heart Failure, Self Care, Quality of Life, Self Efficacy, Home-based care, Nurse-led intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transtheoretical model-based interventionBehavioural
Pretest data are collected for patients in the intervention group in a face-to-face interview in the hospital setting.
The training prepared according to the behavior change phase will be conducted one week later in the patients' home environment and the required data will be collected.
In the fourth week of the research, the patient is visited at home, the training prepared according to the behavior change phase is performed at the patient's home, and the required data will be collected.
In the eighth week of the research, the patient is visited at home, the training prepared according to the behavior change phase is performed at the patient's home, and the required data will be collected.
In the twelfth week of the study, post-tests will be collected in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | Participants in the intervention group received a 12-week nurse-led, Transtheoretical Model-based home education and follow-up programme. The programme included stage-tailored education, symptom monitoring, medication adherence support, daily weight monitoring, salt and fluid management, safe physical activity guidance, healthy nutrition, tobacco control, stress management, motivational interviewing, and individualized behaviour-change planning. Home visits were conducted in weeks 1, 3, 4, 6, 8, and 10. Telephone follow-up was provided in weeks 2, 5, 7, 9, and 11 to review symptoms, medication adherence, weight monitoring, fluid and salt management, physical activity, motivation, barriers to behaviour change, and general clinical status. Post-intervention measurements were conducted in week 12. Receives: Behavioral: transtheoretical model-based intervention |
| Control group | No intervention | Participants in the control group continued routine outpatient cardiology follow-up. Usual care included medical examination, routine clinical monitoring, physician-led medication management when required, and standard verbal recommendations during clinical encounters. They did not receive the Transtheoretical Model-based home education and follow-up intervention during the study period. After study completion, the control group received the educational booklet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Heart Failure Self-Care Behavior Scale
Turkish validity and reliability study of this measurement tool, which measures the self-care behaviors of HF patients, by Baydemir et al. (2013). This scale consists of 12 items, 4 sub-dimensions and a 5-point Likert structure. A low score obtained from the scale indicates high self-care behavior
Measured: 12 weeks
Secondary outcomes (3)
6-Minute Walk Test
The 6-minute walk test is used as a simple measure of aerobic exercise capacity for patients with heart failure. During this test, the patient walks on a 30-meter-long track with a solid surface at a normal pace for six minutes. The patient's vital signs are checked before and during the test. Conditions such as chest pain and severe shortness of breath require the test to be terminated. Patients with mild heart failure usually walk 300-450 metres and advanced patients walk 150-300 metres
Measured: 12 week
Minnesota Living with Heart Failure Questionnaire
The Turkish validity and reliability study of this scale, which measures the quality of life of HF patients, was conducted by Özdemir (2009). This scale consists of 21 items, 2 sub-dimensions and a 6-point structure. A low score obtained from the scale indicates a high quality of life.
Measured: 12 weeks
General Self-Efficacy Scale
The Turkish validity and reliability study of this measurement tool, which measures the self-efficacy level of individuals, was conducted by Aypay (2010). This scale consists of 10 items, 1 sub-dimension and a 4-point Likert structure. A low score obtained from the scale indicates that the general self-efficacy level is low.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Feb 2024
- Primary completion1 Nov 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Hakan ÇELİK, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074887
- Sponsor's protocol ID
- TDK-2023-12974
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
PubMed 35379503Chouinard MC, Robichaud-Ekstrand S. Predictive value of the transtheoretical model to smoking cessation in hospitalized patients with cardiovascular disease. Eur J Cardiovasc Prev Rehabil. 2007 Feb;14(1):51-8. doi: 10.1097/HJR.0b013e328014027b.
PubMed 17301627Degertekin M, Erol C, Ergene O, Tokgozoglu L, Aksoy M, Erol MK, Eren M, Sahin M, Eroglu E, Mutlu B, Kozan O. [Heart failure prevalence and predictors in Turkey: HAPPY study]. Turk Kardiyol Dern Ars. 2012 Jun;40(4):298-308. doi: 10.5543/tkda.2012.65031. Turkish.
PubMed 22951845Gonzalez B, Lupon J, Herreros J, Urrutia A, Altimir S, Coll R, Prats M, Valle V. Patient's education by nurse: what we really do achieve? Eur J Cardiovasc Nurs. 2005 Jun;4(2):107-11. doi: 10.1016/j.ejcnurse.2005.03.006.
PubMed 15904880Li X, Yang S, Wang Y, Yang B, Zhang J. Effects of a transtheoretical model - based intervention and motivational interviewing on the management of depression in hospitalized patients with coronary heart disease: a randomized controlled trial. BMC Public Health. 2020 Mar 30;20(1):420. doi: 10.1186/s12889-020-08568-x.
PubMed 32228532Paradis V, Cossette S, Frasure-Smith N, Heppell S, Guertin MC. The efficacy of a motivational nursing intervention based on the stages of change on self-care in heart failure patients. J Cardiovasc Nurs. 2010 Mar-Apr;25(2):130-41. doi: 10.1097/JCN.0b013e3181c52497.
PubMed 20168193Zhu LX, Ho SC, Sit JW, He HG. The effects of a transtheoretical model-based exercise stage-matched intervention on exercise behavior in patients with coronary heart disease: a randomized controlled trial. Patient Educ Couns. 2014 Jun;95(3):384-92. doi: 10.1016/j.pec.2014.03.013. Epub 2014 Mar 29.
PubMed 24726785Baydemir C, Ozdamar K, Unalir A. Validity of the Turkish version of the European Heart Failure Self-Care Behavior Scale. Anadolu Kardiyol Derg. 2013 Sep;13(6):573-9. doi: 10.5152/akd.2013.141. Epub 2013 May 10.
PubMed 23665988
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse-led, Transtheoretical Model-based Home Education and Follow-up Programme on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06074887
- Acronym / sponsor ID
- TDK-2023-12974
- Conditions
- Heart Failure
- Keywords
- Transtheoretical Model, Cardiac Rehabilitation, Heart Failure, Self Care, Quality of Life, Self Efficacy, Home-based care, Nurse-led intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University, The Scientific and Technological Research Council of Turkey
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 10 Oct 2023 (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.
The main reason why heart failure (HF) is an important public health problem is that the incidence of HF is increasing and mortality rates remain unchanged despite the decline in the incidence of coronary artery disease. The ageing population and improved medical care services are the main factors supporting this increase. In the guidelines, education and rehabilitation are recommended for symptomatic HF patients with the highest level of evidence and recommendation (Class 1A) and considered as an integral part of HF treatment. The aim of this study was to investigate the effect of Transtheoretical Model-based cardiac rehabilitation training on self-care, quality of life and self-efficacy levels of HF patients. The study was conducted with a parallel-group, randomised controlled experimental design with pre-test and post-test measurements. Thirty-two experimental and 31 control patients, randomly assigned according to inclusion and exclusion criteria, were followed up at home for 12 weeks. Transtheoretical Model (TTM)-based CR training was applied to the intervention group through home visits. Data were collected through socio-demographic information form, behaviour change stage diagnostic form, Minnesota Living with Heart Failure Scale, European Heart Failure Self-Care Behaviour Scale, General Self-Efficacy Scale, home visit follow-up chart, patient follow-up form, telephone counselling follow-up chart and general condition assessment form. Number, percentage, mean and standard deviation were used for descriptive statistics; independent and dependent sample t-test, repeated measures ANOVA test, Chi-Square test, Fisher's Exact test, Fisher-Freeman-Halton Exact test, Wilcoxon Signed Ranks test, Mann-Whitney U test and Friedman test were used for comparative analyses. The findings showed that the TTM-based KR programme had a statistically significant effect on increasing the quality of life, self-efficacy and self-care levels and improving the clinical parameters of the patients in the intervention group. Improvement was observed in the NYHA classification of the patients in the intervention group and 96.9% of them were determined to have passed to the 'movement' stage of TTM. It is recommended that home-based CR programmes should be disseminated and health professionals should be trained in TTM-based interventions to improve the general condition and clinical parameters of HF patients. It is also recommended to investigate the effectiveness of TTM-based training programmes in different patient groups and to evaluate their long-term effects.
Detailed description
A total of 74 participants were randomized, and 63 participants completed the 12-week follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Behavioral: transtheoretical model-based interventionParticipants in the intervention group received a 12-week nurse-led, Transtheoretical Model-based home education and follow-up programme. The programme included stage-tailored education, symptom monitoring, medication adherence support, daily weight monitoring, salt and fluid management, safe physical activity guidance, healthy nutrition, tobacco control, stress management, motivational interviewing, and individualized behaviour-change planning. Home visits were conducted in weeks 1, 3, 4, 6, 8, and 10. Telephone follow-up was provided in weeks 2, 5, 7, 9, and 11 to review symptoms, medication adherence, weight monitoring, fluid and salt management, physical activity, motivation, barriers to behaviour change, and general clinical status. Post-intervention measurements were conducted in week 12. |
| Control group | No intervention | –Participants in the control group continued routine outpatient cardiology follow-up. Usual care included medical examination, routine clinical monitoring, physician-led medication management when required, and standard verbal recommendations during clinical encounters. They did not receive the Transtheoretical Model-based home education and follow-up intervention during the study period. After study completion, the control group received the educational booklet. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Unable to participate regularly in the intervention/follow-up Currently enrolled in an active cardiac rehabilitation program Contraindications for cardiac rehabilitation Hypertrophic heart failure Advanced aortic stenosis Angina pectoris Oncological diagnosis Advanced COPD Dialysis treatment Myocardial infarction within the last 6 months Pregnancy Morbid obesity Cognitive dysfunction
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 |
|---|---|---|
| transtheoretical model-based interventionPretest data are collected for patients in the intervention group in a face-to-face interview in the hospital setting. The training prepared according to the behavior change phase will be conducted one week later in the patients' home environment and the required data will be collected. In the fourth week of the research, the patient is visited at home, the training prepared according to the behavior change phase is performed at the patient's home, and the required data will be collected. In the eighth week of the research, the patient is visited at home, the training prepared according to the behavior change phase is performed at the patient's home, and the required data will be collected. In the twelfth week of the study, post-tests will be collected in the hospital. | Behavioural | İntervention group |
Primary outcome
European Heart Failure Self-Care Behavior Scale
Time frame: 12 weeks
Turkish validity and reliability study of this measurement tool, which measures the self-care behaviors of HF patients, by Baydemir et al. (2013). This scale consists of 12 items, 4 sub-dimensions and a 5-point Likert structure. A low score obtained from the scale indicates high self-care behavior
3 secondary outcomes
6-Minute Walk Test
Time frame: 12 week
Minnesota Living with Heart Failure Questionnaire
Time frame: 12 weeks
General Self-Efficacy Scale
Time frame: 12 weeks
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 9 Oct 2026.
- Results publication: PubMed 35379503Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
- Results publication: PubMed 17301627Chouinard MC, Robichaud-Ekstrand S. Predictive value of the transtheoretical model to smoking cessation in hospitalized patients with cardiovascular disease. Eur J Cardiovasc Prev Rehabil. 2007 Feb;14(1):51-8. doi: 10.1097/HJR.0b013e328014027b.
- Results publication: PubMed 22951845Degertekin M, Erol C, Ergene O, Tokgozoglu L, Aksoy M, Erol MK, Eren M, Sahin M, Eroglu E, Mutlu B, Kozan O. [Heart failure prevalence and predictors in Turkey: HAPPY study]. Turk Kardiyol Dern Ars. 2012 Jun;40(4):298-308. doi: 10.5543/tkda.2012.65031. Turkish.
- Results publication: PubMed 15904880Gonzalez B, Lupon J, Herreros J, Urrutia A, Altimir S, Coll R, Prats M, Valle V. Patient's education by nurse: what we really do achieve? Eur J Cardiovasc Nurs. 2005 Jun;4(2):107-11. doi: 10.1016/j.ejcnurse.2005.03.006.
- Results publication: PubMed 32228532Li X, Yang S, Wang Y, Yang B, Zhang J. Effects of a transtheoretical model - based intervention and motivational interviewing on the management of depression in hospitalized patients with coronary heart disease: a randomized controlled trial. BMC Public Health. 2020 Mar 30;20(1):420. doi: 10.1186/s12889-020-08568-x.
- Results publication: PubMed 20168193Paradis V, Cossette S, Frasure-Smith N, Heppell S, Guertin MC. The efficacy of a motivational nursing intervention based on the stages of change on self-care in heart failure patients. J Cardiovasc Nurs. 2010 Mar-Apr;25(2):130-41. doi: 10.1097/JCN.0b013e3181c52497.
- Results publication: PubMed 24726785Zhu LX, Ho SC, Sit JW, He HG. The effects of a transtheoretical model-based exercise stage-matched intervention on exercise behavior in patients with coronary heart disease: a randomized controlled trial. Patient Educ Couns. 2014 Jun;95(3):384-92. doi: 10.1016/j.pec.2014.03.013. Epub 2014 Mar 29.
- Results publication: PubMed 23665988Baydemir C, Ozdamar K, Unalir A. Validity of the Turkish version of the European Heart Failure Self-Care Behavior Scale. Anadolu Kardiyol Derg. 2013 Sep;13(6):573-9. doi: 10.5152/akd.2013.141. Epub 2013 May 10.
- Özdemir, V. A. (2009). Kronik kalp yetmezliği olan hastalarda yaşam kalitesinin değerlendirilmesi (Doctoral dissertation, Marmara Universitesi (Turkey)).Link provided by the sponsor.
- Aypay, A. 2010. "Öz yeterlik ölçeğinin Türkçe'ye uyarlama çalışması", İnönü Üniversitesi Eğitim Fakültesi Dergisi, 11(2), 113-131.Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transtheoretical model-based intervention in people with Heart Failure, run by Cukurova University at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
European Heart Failure Self-Care Behavior Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074887, which also lists 8 linked publications.
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 9 Oct 2026.