Rehabilitation After Heart FailureNCT01239667
Rehabilitative Care to Patients With Heart Failure
A study testing Individual oriented planning of the rehabilitation program for patients with heart failure in people with Rehabilitation After Heart Failure, run by University College Absalon at 1 site in Denmark.
Trial summary
Hypothesis and objectives of the study Systematic preparation of rehabilitation plan for rehabilitation in Phase III based on identification of self-care behavior patients with heart failure in NYHA class II and III, leading to patients' self-care behaviors strengthened, which will result in increased health status… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation After Heart Failure
- What is being tested?
- Individual oriented planning of the rehabilitation program for patients with heart failure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Feb 2012
- 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
None listed.
Who cannot join
- Patients who do not wish to participate. Patients with language and communication impedes Sufficient participation. Patients who do not understand information, as well as patients diagnosed with neurological deficits.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University of Aarhus Denmark
Aarhus, Aarhus, 8000
Preben Petersen, Lecturer Ph.d, pup53@post.cybercity.dk
Palle Larsen, MSn,ph.d stud
About this study
Hypothesis and objectives of the study Systematic preparation of rehabilitation plan for rehabilitation in Phase III based on identification of self-care behavior patients with heart failure in NYHA class II and III, leading to patients' self-care behaviors strengthened, which will result in increased health status and ADL level 6 months after discharge from hospital with heart failure .
Target
Read more
- To develop evidence-based clinical guidelines for patient rehabilitation phase III
- To test the effect of individual rehabilitation plans based on clinical guidelines for patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in self-care behaviors, health status and ADL function.
Material and Methods:
Controlled longitudinal study. Each intervention patient receives before the end of hospital rehabilitation designed a specific rehabilitation plan also contacted the patient by specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in hospital and the patient has the opportunity to contact the department when needed. The effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9, to assess patients' ADL functioning, self-care behaviors and self-rated health.
All patients participating in the planned rehabilitation in hospitals, so that the baseline is the end of Phase II. Intervention based on an analysis of the individual's need for continued rehabilitation (self care behavior, health status, ADL function) and the patient's perception of own situation. Draw up a plan and program together with the patient
Read the detailed description
Rehabilitation for people with serious illness, has been in focus over the last 10-15 years which is also valid for heart field (1). The focus of cardiac rehabilitation has been on the efficacy of treatment in relation to mortality, morbidity and health-related quality of life (HRQoL).
Purpose of rehabilitation are:
"Rehabilitation is a targeted and time-bound collaborative process between an individual, relatives and professionals. The aim is that citizens who have or are at risk of significant limitations in physical, mental and / or social functioning, achieve an independent and meaningful life. Rehabilitation based on the citizen's whole life situation and decisions made by a coordinated, coherent, knowledge-based action (1).
Background. Worldwide, estimated that around. 50 million people suffer from heart disease (2). In Denmark assumed that 60,000 people live with chronic heart failure, with prevalence increasing with increasing age (3) (4). In 2005 there were 142,245 hospitalizations with cardiovascular disease in Denmark, by 86,336 people, 1,786 per 100,000 men and 1,409 per 100,000 women. Viewed in isolation on heart-related deaths in the period 1998 -2005 is a decrease in mortality in general, and in 30 day mortality after AMI decreased from 10 to 4% (5). Cardiac rehabilitation has been made in traditional hospital setting and there is a documented effect of effort in terms of patients' physical function, decrease in relapse of disease, and decrease in morbidity and mortality (2) (6) (7) (8) (9).
Hypothesis and objectives of the study Hypothesis: Systematic preparation of rehabilitation plan in Phase III based on the identification of self care behavior patients with heart failure in NYHA class II and III, leading to patients' self-care behaviors strengthened, which will result in improved health status and ADL level 6 months after discharge from hospital with heart failure .
Target
- To develop evidence-based protocol for patient rehabilitation phase III
- To test the effect of individual rehabilitation plans based on evidence-based knowledge of patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in self-care behaviors, health status and ADL function.
Materials and methods. 3.1 Population: Patients recruited from Zealand Region Hospital South in Naestved and Slagelse. There are printed annually 55-60 patients with heart failure from each of the respective hospitals. The material in the study are women and men with heart failure in NYHA class II - III of participants are calculated based on strength calculation.
Inclusion:
Patients in NYHA II-III Participation happens after written informed consent. Patients included in the respective intervention or control group depending on the hospital site.
Exclusion:
Patients who do not wish to participate. Patients with language and communication impedes Sufficient participation. Patients who do not understand information, as well as patients diagnosed with neurological deficits.
Calculation of sample size:
Calculation of patient numbers are based on strength calculation. The level of type 1 error set at 5% and type 2 errors to 20%, and expected an improvement in ADL level at 50%, Power Calculation shows that the participating 60 patients in the control and 60 patients in the intervention group (http:/ / statpages.org / proppowr.html). With an expected dropout rate of 25%, therefore, invited 72 patients in each group
Design. quasi experimental study of patients from the Regions Hospital in Naestved and the hospital in Slagelse. Each intervention patient receives before the end of hospital rehabilitation designed a specific rehabilitation plan also contacted the patient by specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in hospital and the patient has the opportunity to contact the department when needed. The effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9 (36) to assess patients' ADL functioning, self-care behaviors and self-rated health. Patients included in the experimental and control group. Randomization and blinding is not possible since the staffing resources are not sufficient to enable the staff only have contact with the respective intervention or control patients.
All patients participating in the planned rehabilitation in hospitals, so that the baseline is the end of Phase II. Intervention based on an analysis of the individual's need for continued rehabilitation (selfcare behavior, health status, ADL function) and the patient's perception of own situation. Draw up a plan and program together with the patient. The program must be tailored to the individual patient's possibilities. The program supplied with guides to what the patient can do yourself. The patient acknowledged copy of the plan to your physician and home care. Furthermore, the patient will be contacted by specially trained nurse telephone 4 and 12 weeks after initiation of phase III rehabilitation, providing telephone support from a structured interview guide. Patients also have the opportunity outside the agreed times to contact the specialist nurse.
Variables: Demographic data, sex, age, living alone, dependent / independent of help from others, diagnosis, status of job, comorbidities, NYHA class
NYHA classification is carried out by specialists at discharge from hospital and transition to rehabilitation
Self-Care Behavior and ADL functions, estimated using the European Heart Failure Self-Care Behavior Scale. The instrument is translated and face validated in a pilot test before use. The test measures patients' ability to assess their own situation and ability to act on the observations made (36).
Health Status Assessed with Short Form 36 (SF-36). The form is generic and covers the patient's perception of their health. SF-36 has been translated into Danish and validated (37). SF-36 includes 36 questions on self-assessment of health status that includes eight specific areas: physical functioning, physical constraints, pain, general health, energy / fatigue, social functioning, psychological constraints and psychological wellbeing. For each of the eight strands transformed responses to an interval scale from 0-100 where 0 indicates no impairment or full restriction and 100 indicates full function or no restriction.
Process variable: compliance over nursing program examined self-reported data.
Statistical analysis:
Data will be analyzed in the statistical program SPSS. Ratio-scaled data from the two groups is tested by F test MHP. of distribution. For normally distributed data are compared by using parametric methods (t test), otherwise non-parametric methods (Mann-Whitney Rank Sum Test). Nominal Scale Data compared by chi-square test or by using 95% confidence interval.
The project reported to the Data Inspectorate. Furthermore, the experiment reported to the local Research Ethics Committee, and to www.Clinicaltrials.gov so that rights to the project ensured.
.
- Conditions
- Rehabilitation After Heart Failure
- Being tested
- Individual oriented planning of the rehabilitation program for patients with heart failure
- Keywords
- Health related quality of Life, Self Care behavior, activities of daily living
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual oriented planning of the rehabilitation program for patients with heart failureOther
Individual oriented rehabilitation plan in collaboration with the patient followed by measuring health related quality of life and self care behavior
| Study group | Role | What they receive |
|---|---|---|
| Life style counseling | Experimental | Individual oriented rehabilitation plan in collaboration with the patient followed by measuring health related quality of life and self care behavior Receives: Other: Individual oriented planning of the rehabilitation program for patients with heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Evidence for health related quality of life in heart failure patients in the rehabilitation phase, measured with instrument SF 36
Measured: Measured 6 month after discharge from hospital
Self Care Behavior
Mesure the patients self care behavior by using the instrument European Heart Failure Self Care Behavior Scale
Measured: measured 6 month after discharge
Activities of Daily Living
measure the patients PADL and IADL functions
Measured: 6 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation After Heart FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Absalon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Investigators
- Palle Larsen, MSN and Ph.d. student, Principal investigator, Univcersity College Sjaelland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239667
- Sponsor's protocol ID
- pla123
- Status last verified
- Oct 2010
- First submitted
- 25 Oct 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitative Care to Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01239667
- Acronym / sponsor ID
- pla123
- Conditions
- Rehabilitation After Heart Failure
- Keywords
- Health related quality of Life, Self Care behavior, activities of daily living
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- University College AbsalonUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Sep 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 11 Nov 2010 (estimated)
- 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.
Hypothesis and objectives of the study Systematic preparation of rehabilitation plan for rehabilitation in Phase III based on identification of self-care behavior patients with heart failure in NYHA class II and III, leading to patients' self-care behaviors strengthened, which will result in increased health status and ADL level 6 months after discharge from hospital with heart failure .
Target
- To develop evidence-based clinical guidelines for patient rehabilitation phase III
- To test the effect of individual rehabilitation plans based on clinical guidelines for patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in self-care behaviors, health status and ADL function.
Material and Methods:
Controlled longitudinal study. Each intervention patient receives before the end of hospital rehabilitation designed a specific rehabilitation plan also contacted the patient by specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in hospital and the patient has the opportunity to contact the department when needed. The effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9, to assess patients' ADL functioning, self-care behaviors and self-rated health.
All patients participating in the planned rehabilitation in hospitals, so that the baseline is the end of Phase II. Intervention based on an analysis of the individual's need for continued rehabilitation (self care behavior, health status, ADL function) and the patient's perception of own situation. Draw up a plan and program together with the patient
Detailed description
Rehabilitation for people with serious illness, has been in focus over the last 10-15 years which is also valid for heart field (1). The focus of cardiac rehabilitation has been on the efficacy of treatment in relation to mortality, morbidity and health-related quality of life (HRQoL).
Purpose of rehabilitation are:
"Rehabilitation is a targeted and time-bound collaborative process between an individual, relatives and professionals. The aim is that citizens who have or are at risk of significant limitations in physical, mental and / or social functioning, achieve an independent and meaningful life. Rehabilitation based on the citizen's whole life situation and decisions made by a coordinated, coherent, knowledge-based action (1).
Background. Worldwide, estimated that around. 50 million people suffer from heart disease (2). In Denmark assumed that 60,000 people live with chronic heart failure, with prevalence increasing with increasing age (3) (4). In 2005 there were 142,245 hospitalizations with cardiovascular disease in Denmark, by 86,336 people, 1,786 per 100,000 men and 1,409 per 100,000 women. Viewed in isolation on heart-related deaths in the period 1998 -2005 is a decrease in mortality in general, and in 30 day mortality after AMI decreased from 10 to 4% (5). Cardiac rehabilitation has been made in traditional hospital setting and there is a documented effect of effort in terms of patients' physical function, decrease in relapse of disease, and decrease in morbidity and mortality (2) (6) (7) (8) (9).
Hypothesis and objectives of the study Hypothesis: Systematic preparation of rehabilitation plan in Phase III based on the identification of self care behavior patients with heart failure in NYHA class II and III, leading to patients' self-care behaviors strengthened, which will result in improved health status and ADL level 6 months after discharge from hospital with heart failure .
Target
- To develop evidence-based protocol for patient rehabilitation phase III
- To test the effect of individual rehabilitation plans based on evidence-based knowledge of patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in self-care behaviors, health status and ADL function.
Materials and methods. 3.1 Population: Patients recruited from Zealand Region Hospital South in Naestved and Slagelse. There are printed annually 55-60 patients with heart failure from each of the respective hospitals. The material in the study are women and men with heart failure in NYHA class II - III of participants are calculated based on strength calculation.
Inclusion:
Patients in NYHA II-III Participation happens after written informed consent. Patients included in the respective intervention or control group depending on the hospital site.
Exclusion:
Patients who do not wish to participate. Patients with language and communication impedes Sufficient participation. Patients who do not understand information, as well as patients diagnosed with neurological deficits.
Calculation of sample size:
Calculation of patient numbers are based on strength calculation. The level of type 1 error set at 5% and type 2 errors to 20%, and expected an improvement in ADL level at 50%, Power Calculation shows that the participating 60 patients in the control and 60 patients in the intervention group (http:/ / statpages.org / proppowr.html). With an expected dropout rate of 25%, therefore, invited 72 patients in each group
Design. quasi experimental study of patients from the Regions Hospital in Naestved and the hospital in Slagelse. Each intervention patient receives before the end of hospital rehabilitation designed a specific rehabilitation plan also contacted the patient by specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in hospital and the patient has the opportunity to contact the department when needed. The effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9 (36) to assess patients' ADL functioning, self-care behaviors and self-rated health. Patients included in the experimental and control group. Randomization and blinding is not possible since the staffing resources are not sufficient to enable the staff only have contact with the respective intervention or control patients.
All patients participating in the planned rehabilitation in hospitals, so that the baseline is the end of Phase II. Intervention based on an analysis of the individual's need for continued rehabilitation (selfcare behavior, health status, ADL function) and the patient's perception of own situation. Draw up a plan and program together with the patient. The program must be tailored to the individual patient's possibilities. The program supplied with guides to what the patient can do yourself. The patient acknowledged copy of the plan to your physician and home care. Furthermore, the patient will be contacted by specially trained nurse telephone 4 and 12 weeks after initiation of phase III rehabilitation, providing telephone support from a structured interview guide. Patients also have the opportunity outside the agreed times to contact the specialist nurse.
Variables: Demographic data, sex, age, living alone, dependent / independent of help from others, diagnosis, status of job, comorbidities, NYHA class
NYHA classification is carried out by specialists at discharge from hospital and transition to rehabilitation
Self-Care Behavior and ADL functions, estimated using the European Heart Failure Self-Care Behavior Scale. The instrument is translated and face validated in a pilot test before use. The test measures patients' ability to assess their own situation and ability to act on the observations made (36).
Health Status Assessed with Short Form 36 (SF-36). The form is generic and covers the patient's perception of their health. SF-36 has been translated into Danish and validated (37). SF-36 includes 36 questions on self-assessment of health status that includes eight specific areas: physical functioning, physical constraints, pain, general health, energy / fatigue, social functioning, psychological constraints and psychological wellbeing. For each of the eight strands transformed responses to an interval scale from 0-100 where 0 indicates no impairment or full restriction and 100 indicates full function or no restriction.
Process variable: compliance over nursing program examined self-reported data.
Statistical analysis:
Data will be analyzed in the statistical program SPSS. Ratio-scaled data from the two groups is tested by F test MHP. of distribution. For normally distributed data are compared by using parametric methods (t test), otherwise non-parametric methods (Mann-Whitney Rank Sum Test). Nominal Scale Data compared by chi-square test or by using 95% confidence interval.
The project reported to the Data Inspectorate. Furthermore, the experiment reported to the local Research Ethics Committee, and to www.Clinicaltrials.gov so that rights to the project ensured.
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Life style counseling | Experimental | Other: Individual oriented planning of the rehabilitation program for patients with heart failureIndividual oriented rehabilitation plan in collaboration with the patient followed by measuring health related quality of life and self care behavior |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients who do not wish to participate. Patients with language and communication impedes Sufficient participation. Patients who do not understand information, as well as patients diagnosed with neurological deficits.
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 |
|---|---|---|
| Individual oriented planning of the rehabilitation program for patients with heart failureIndividual oriented rehabilitation plan in collaboration with the patient followed by measuring health related quality of life and self care behavior | Other | Life style counseling |
Primary outcome
Health related quality of life
Time frame: Measured 6 month after discharge from hospital
Evidence for health related quality of life in heart failure patients in the rehabilitation phase, measured with instrument SF 36
Self Care Behavior
Time frame: measured 6 month after discharge
Mesure the patients self care behavior by using the instrument European Heart Failure Self Care Behavior Scale
Activities of Daily Living
Time frame: 6 month after discharge
measure the patients PADL and IADL functions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
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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.
Palle Larsen, MSN and Ph.d. student principal investigator
Univcersity College Sjaelland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual oriented planning of the rehabilitation program for patients with heart failure in people with Rehabilitation After Heart Failure, run by University College Absalon 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 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: status not confirmed, as of the sponsor's last update on 11 Nov 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Palle Larsen, MSN and ph,.d student (+4572481278, pla@ucsj.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: Measured 6 month after discharge from hospital). 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 11 Nov 2010.