Cardiac RehabilitationNCT03734185
Cardiac Rehabilitation: From Hospital to Municipal Setting.
A study testing Learning and Coping in people with Cardiac Rehabilitation, run by Defactum, Central Denmark Region at 1 site in Denmark.
Trial summary
In recent decades, local healthcare services have undergone dramatic changes. The World Health Organization (WHO) refers to a shift from specialized hospital to local healthcare services to meet the growing expectations for better performance and outcomes in health care and better value for money. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Learning and Coping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 31 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We include all adult patients ( >18 years old) discharged from hospital with in Central Denmark Region between September 1, 2018 and July 31, 2019. Ischaemic Heart Disease will be defined according to the International Classification of Diseases version 10 (ICD-10): DI210, DI210A, DI210B, DI211, DI211A, DI211B, DI213, DI214, DI219, DI248, DI249, DI240, DI209, DI251, DI251B, and DI251. In 2016, this population represented approx. 2,700 patients.
Who cannot join
- People survive cardiac arrest
Trial locations and contacts
1 site in 1 country.
About this study
In recent decades, local healthcare services have undergone dramatic changes. The World Health Organization (WHO) refers to a shift from specialized hospital to local healthcare services to meet the growing expectations for better performance and outcomes in health care and better value for money. It is unique that Central Denmark Region has assigned phase II cardiac rehabilitation (CR) as a local healthcare task. However, there is sparse knowledge about how this reform may influence processes of care and outcomes in CR. This association is important to investigate when dramatic organisational changes in settings of evidence based interventions is implemented, as well as in relation to helping people with heart disease return to an active and satisfying everyday life.
Read the detailed description
Background In recent decades, local healthcare services have undergone dramatic changes. The World Health Organization (WHO) refers to a shift from specialized hospital to local healthcare services to meet the growing expectations for better performance and outcomes in health care and better value for money. In line with the WHO statements a structural reform reorganised the entire public sector in Denmark in 2007. The local healthcare services were given the responsibility for the more generalised rehabilitation of patients with chronic diseases, and hospitals were to carry out more specialised rehabilitation for patients with chronic diseases admitted to a hospital. Today, several local healthcare services provide non-pharmacological phase II cardiac rehabilitation (CR); this phase encompasses the immediate post discharged period. Central Denmark Region has - as the only region in Denmark - assigned phase II CR as a local healthcare task. This unique reform became effective on 1 January, 2017. However, there is sparse knowledge about how this reform may influence processes of care and outcomes in CR.
CR programmes do not meet the required evidence-based standard Several countries have developed clinical practice guidelines for CR, including Denmark in 2013. The guidelines incorporate the best available evidence for the management of CR to assist health professionals and patient decisions about appropriate rehabilitation. However, it is unclear to what extent local healthcare services CR is performed in accordance with the clinical practice guidelines for CR. Doherty P et al. studied the extent to which programmes meet national minimum standards for the delivery of CR as prescribed by the National Certification Programme for CR in UK. The authors found that 31% out of 170 unique CR programmes were delivered with high performance, 46% as mid-level performance, 18% were lower-level, while 5% failed to meet any of the minimum criteria. We have not been able to find other similar studies for performance of CR programmes in Denmark or elsewhere. Therefore, it is unclear whether the performance varies in local healthcare services CR programmes in Denmark, and whether there is a need for improvement to provide all patients a high-quality evidence-based service.
Patient education using learning and coping improves adherence Patient education is recommended in the clinical practice guidelines for CR and is defined as: "The process by which health professionals and others impact information to patients who will change their health behaviors or improve their health status". In the guidelines several educational topics are listed as important for patient education. However, the rationale for the specific areas is not completely explained in the guidelines. Furthermore, the guidelines only advice on what to teach, not how it should be done e.g. educational models, material, provider and setting. A systematic review shows that the delivery of patient education programmes can vary substantially, but common topics include nutrition, exercise, risk factor modification, psychosocial well-being and medications. Also duration, frequency and ongoing maintenance or re-inforcement vary between programmes. However, the Danish Health Authority recommend using evidence-based methods in patient education including Learning and Coping, Motivational interview.
In Central Denmark Region, six out of 19 local healthcare services have decided to use Learning and Coping in CR while remaining local healthcare services use different approaches. Learning and Coping is a health pedagogical strategy that builds on inductive teaching with high involvement of the participants. Characteristics of Learning and Coping are that 'experienced patients' plan, teach and evaluate, in cooperation with health professionals. In a hospital setting, Learning and Coping has shown an increase inpatient adherence in CR including training and patient education, especially for those with low socioeconomic status. However, it is unclear whether using Learning and Coping in local healthcare services performs similar results. These results are needed because low socioeconomic status is a common barrier to attending CR programmes.
Patient education using Learning and Coping to overcome barriers to CR System-, physical- and personal-level barriers in CR are well-described in the literature. Studies show that 13% to 20% of eligible patients are not referred to CR, and 19% to 45% do not attend CR. Also, long wait time to CR after referral entail low attendance. Health-related factors such as anxiety, depression, pain, or other illnesses are reported curtail the uptake. Like exercise-limiting comorbidities predict fewer sessions. Older adults, women, people who belong to ethnic minority groups, are young, have low socioeconomic status, live alone and receive limited social support are low attenders. Other studies show that family obligations and the distance from home to the programme setting entail low attendance. Few studies found that self-payment is a barrier to attend CR. This may not be an issue in Denmark as the Danish healthcare system provides tax-funded healthcare to the country's 5.7 million residents, including free access to hospital care, general practitioners and primary healthcare services including CR. Patients should be encouraged to attend patient education as literature reviews show that educational interventions with cardiac care increase patients' knowledge and facilitate behavior change. Furthermore, education interventions increase physical activity and lead to healthier dietary habits, smoking cessation and a higher quality of life.
It is unique that Central Denmark Region has assigned phase II CR as a local healthcare services. Thus, it is crucial to know more about performance in local healthcare services CR and whether all patients receive high-quality evidence-based services regardless of where they live. To our knowledge, no studies have examined the association between performance in different health pedagogical strategies and outcomes. This association is important to investigate when dramatic organisational changes in settings of evidence based interventions is implemented, as well as in relation to helping people with heart disease return to an active and satisfying everyday life. This study is unique and may inform and affect the way CR is organised and performed on a national and an international level to improve quality of care.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Learning and Coping
- Keywords
- Cardiac Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning and CopingOther
'Experienced patients' plan, teach and evaluate, in cooperation with health professionals.
| Study group | Role | What they receive |
|---|---|---|
| Learning and Coping | Experimental | A health pedagogical strategy that builds on inductive teaching with high involvement of the participants. Characteristics of Learning and Coping are that 'experienced patients' plan, teach and evaluate, in cooperation with health professionals. Receives: Other: Learning and Coping |
| Usual Cardiac Rehabilitation | Active comparator | The theoretical frameworks used in some of these local healthcare services are empowerment, self-efficacy and self-management Receives: Other: Learning and Coping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Adherence to CR, defined as percentage of total prescribed sessions.
Measured: During a 12 week programme
Secondary outcomes (6)
Health-related quality of life
Questionnaire; HearQol The HeartQol questionnaire assesses health-related quality of life; physical and emotional condition. The HeartQoL questionnaire was first described in the literature in 2012. It is a 14-item assessment and evaluation system specific to IHD that assesses the impact of cardiac intervention on patient-reported health-related quality of life. HeartQoL consists of two subscales, a 10-item physical subscale and a 4-item emotional subscale. Scores range from 0 to 3 with higher scores indicating a better health-related quality of life. The HeartQol questionnaire has been validated in Danish patients with heart valve surgery.
Measured: 4 times during 12 months after engaging Cardia Rehabilitation
Anxiety and depression
Questionnaire; HADS Hospital Anxiety and Depression Scale assesses states of depression and anxiety in the setting of an hospital medical outpatient clinic and primary care population. The scale consist of 14 items - seven concerning anxiety and seven concerning depression An analysis of scores on the two subscales of a further sample, in the same clinical setting, showed that a score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 11 or higher indicating probable presence ('caseness') of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state. The Hospital Anxiety and Depression Scale is a valid and reliable instrument that has been used across the world in cardiac and non-cardiac populations.
Measured: 4 times during 12 months after engaging Cardia Rehabilitation
Coping
Questionnaire; PAM The Patient Activation Measure assesses the patients' activation level in four elements; knowledge, skills, confidence and behaviours. The scale consists of 13-items. The Patient Activation Measure identifies four different levels of activation. The Patient Activation Measure is a valid and reliable instrument that has been used across the world in populations with chronic diseases. The Patient Activation Measure is translated and validated in Danish setting.
Measured: 4 times during 12 months after engaging Cardia Rehabilitation
Return to work
Sick leave and work disability are registered in the Danish Register for Evaluation of Marginalisation (DREAM). DREAM includes all Danish citizens who have received social benefits or any other public benefits since July 1991. Transfer benefits, which can be grouped into five categories: Benefits to otherwise self-supporting individuals, labor market-related benefits, temporary health-related benefits (sickness benefit and vocational rehabilitation benefit), permanent health-related benefits (partial and full disability pension), and benefits related to old age or early retirement. If no transfer income is registered for a specific week, the person is considered to be self-supporting or on short-term sick-leave (less than 2 weeks). In Denmark, a citizen in the workforce (employed as well as unemployed) is entitled to sickness absence compensation, and in case the employee receives normal salary during sick leave, the employer receives a municipal reimbursement.
Measured: 12 months after ended Cardiac Rehabilitation
Cost-effectiveness
EQ-5D assesses health related quality of life and practical for economic evaluation. Patients are asked to complete the questionnaire at baseline and 12 months after the completed CR. EQ-5D was first introduced in 1990 by the EuroQol Group. The EQ-5D has been extensively used to assess patient utility in trials of new treatments. The index-based score is generated by applying societal preference weights to the health state classification completed by the patient that consists of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each with three levels of response or severity (no problems, some problems, or extreme problems). The ability to convert self classification responses into a single index score makes the EQ-5D practical for clinical and economic evaluation.
Measured: When patients enter intervention CR or usual CR and again 12 months after ended CR
Completion
Completion is final CR assessment and discharge to long term management from primary health service. This information is obtained from the Central Denmark Region Cardiac Rehabilitation Database - recorded: yes/no
Measured: At the end of a 12 week rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Sep 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defactum, Central Denmark Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Charlotte Gjørup Pedersen, PhD, Principal investigator, Defactum, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734185
- Sponsor's protocol ID
- Cardiac Rehab
- Status last verified
- Jun 2022
- First submitted
- 19 Oct 2018
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation: From Hospital to Municipal Setting.
- ClinicalTrials.gov ID
- NCT03734185
- Acronym / sponsor ID
- Cardiac Rehab
- Conditions
- Cardiac Rehabilitation
- Keywords
- Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Defactum, Central Denmark RegionOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 7 Nov 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 recent decades, local healthcare services have undergone dramatic changes. The World Health Organization (WHO) refers to a shift from specialized hospital to local healthcare services to meet the growing expectations for better performance and outcomes in health care and better value for money. It is unique that Central Denmark Region has assigned phase II cardiac rehabilitation (CR) as a local healthcare task. However, there is sparse knowledge about how this reform may influence processes of care and outcomes in CR. This association is important to investigate when dramatic organisational changes in settings of evidence based interventions is implemented, as well as in relation to helping people with heart disease return to an active and satisfying everyday life.
Detailed description
Background In recent decades, local healthcare services have undergone dramatic changes. The World Health Organization (WHO) refers to a shift from specialized hospital to local healthcare services to meet the growing expectations for better performance and outcomes in health care and better value for money. In line with the WHO statements a structural reform reorganised the entire public sector in Denmark in 2007. The local healthcare services were given the responsibility for the more generalised rehabilitation of patients with chronic diseases, and hospitals were to carry out more specialised rehabilitation for patients with chronic diseases admitted to a hospital. Today, several local healthcare services provide non-pharmacological phase II cardiac rehabilitation (CR); this phase encompasses the immediate post discharged period. Central Denmark Region has - as the only region in Denmark - assigned phase II CR as a local healthcare task. This unique reform became effective on 1 January, 2017. However, there is sparse knowledge about how this reform may influence processes of care and outcomes in CR.
CR programmes do not meet the required evidence-based standard Several countries have developed clinical practice guidelines for CR, including Denmark in 2013. The guidelines incorporate the best available evidence for the management of CR to assist health professionals and patient decisions about appropriate rehabilitation. However, it is unclear to what extent local healthcare services CR is performed in accordance with the clinical practice guidelines for CR. Doherty P et al. studied the extent to which programmes meet national minimum standards for the delivery of CR as prescribed by the National Certification Programme for CR in UK. The authors found that 31% out of 170 unique CR programmes were delivered with high performance, 46% as mid-level performance, 18% were lower-level, while 5% failed to meet any of the minimum criteria. We have not been able to find other similar studies for performance of CR programmes in Denmark or elsewhere. Therefore, it is unclear whether the performance varies in local healthcare services CR programmes in Denmark, and whether there is a need for improvement to provide all patients a high-quality evidence-based service.
Patient education using learning and coping improves adherence Patient education is recommended in the clinical practice guidelines for CR and is defined as: "The process by which health professionals and others impact information to patients who will change their health behaviors or improve their health status". In the guidelines several educational topics are listed as important for patient education. However, the rationale for the specific areas is not completely explained in the guidelines. Furthermore, the guidelines only advice on what to teach, not how it should be done e.g. educational models, material, provider and setting. A systematic review shows that the delivery of patient education programmes can vary substantially, but common topics include nutrition, exercise, risk factor modification, psychosocial well-being and medications. Also duration, frequency and ongoing maintenance or re-inforcement vary between programmes. However, the Danish Health Authority recommend using evidence-based methods in patient education including Learning and Coping, Motivational interview.
In Central Denmark Region, six out of 19 local healthcare services have decided to use Learning and Coping in CR while remaining local healthcare services use different approaches. Learning and Coping is a health pedagogical strategy that builds on inductive teaching with high involvement of the participants. Characteristics of Learning and Coping are that 'experienced patients' plan, teach and evaluate, in cooperation with health professionals. In a hospital setting, Learning and Coping has shown an increase inpatient adherence in CR including training and patient education, especially for those with low socioeconomic status. However, it is unclear whether using Learning and Coping in local healthcare services performs similar results. These results are needed because low socioeconomic status is a common barrier to attending CR programmes.
Patient education using Learning and Coping to overcome barriers to CR System-, physical- and personal-level barriers in CR are well-described in the literature. Studies show that 13% to 20% of eligible patients are not referred to CR, and 19% to 45% do not attend CR. Also, long wait time to CR after referral entail low attendance. Health-related factors such as anxiety, depression, pain, or other illnesses are reported curtail the uptake. Like exercise-limiting comorbidities predict fewer sessions. Older adults, women, people who belong to ethnic minority groups, are young, have low socioeconomic status, live alone and receive limited social support are low attenders. Other studies show that family obligations and the distance from home to the programme setting entail low attendance. Few studies found that self-payment is a barrier to attend CR. This may not be an issue in Denmark as the Danish healthcare system provides tax-funded healthcare to the country's 5.7 million residents, including free access to hospital care, general practitioners and primary healthcare services including CR. Patients should be encouraged to attend patient education as literature reviews show that educational interventions with cardiac care increase patients' knowledge and facilitate behavior change. Furthermore, education interventions increase physical activity and lead to healthier dietary habits, smoking cessation and a higher quality of life.
It is unique that Central Denmark Region has assigned phase II CR as a local healthcare services. Thus, it is crucial to know more about performance in local healthcare services CR and whether all patients receive high-quality evidence-based services regardless of where they live. To our knowledge, no studies have examined the association between performance in different health pedagogical strategies and outcomes. This association is important to investigate when dramatic organisational changes in settings of evidence based interventions is implemented, as well as in relation to helping people with heart disease return to an active and satisfying everyday life. This study is unique and may inform and affect the way CR is organised and performed on a national and an international level to improve quality of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learning and Coping | Experimental | Other: Learning and CopingA health pedagogical strategy that builds on inductive teaching with high involvement of the participants. Characteristics of Learning and Coping are that 'experienced patients' plan, teach and evaluate, in cooperation with health professionals. |
| Usual Cardiac Rehabilitation | Active comparator | Other: Learning and CopingThe theoretical frameworks used in some of these local healthcare services are empowerment, self-efficacy and self-management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We include all adult patients ( >18 years old) discharged from hospital with in Central Denmark Region between September 1, 2018 and July 31, 2019. Ischaemic Heart Disease will be defined according to the International Classification of Diseases version 10 (ICD-10): DI210, DI210A, DI210B, DI211, DI211A, DI211B, DI213, DI214, DI219, DI248, DI249, DI240, DI209, DI251, DI251B, and DI251. In 2016, this population represented approx. 2,700 patients.
Key exclusion criteria (1 listed)
- People survive cardiac arrest
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 |
|---|---|---|
| Learning and Coping'Experienced patients' plan, teach and evaluate, in cooperation with health professionals. | Other | Learning and Coping, Usual Cardiac Rehabilitation |
Primary outcome
Adherence
Time frame: During a 12 week programme
Adherence to CR, defined as percentage of total prescribed sessions.
6 secondary outcomes
Health-related quality of life
Time frame: 4 times during 12 months after engaging Cardia Rehabilitation
Anxiety and depression
Time frame: 4 times during 12 months after engaging Cardia Rehabilitation
Coping
Time frame: 4 times during 12 months after engaging Cardia Rehabilitation
Return to work
Time frame: 12 months after ended Cardiac Rehabilitation
Cost-effectiveness
Time frame: When patients enter intervention CR or usual CR and again 12 months after ended CR
Completion
Time frame: At the end of a 12 week rehabilitation program
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 Jul 2025.
- Individual participant dataSharing planned: No
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King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
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Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
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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.
Charlotte Gjørup Pedersen, PhD principal investigator
Defactum, Central Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning and Coping in people with Cardiac Rehabilitation, run by Defactum, Central Denmark Region at 1 site in Denmark.
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 1 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 Jul 2025. 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 Denmark. 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?
Adherence (time frame: During a 12 week programme). 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 9 Jul 2025.