Rehabilitation After Heart Failure Clinical Trial
Official title:
Rehabilitative Care to Patients With Heart Failure
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
1. To develop evidence-based clinical guidelines for patient rehabilitation phase III
2. 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
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
1. To develop evidence-based protocol for patient rehabilitation phase III
2. 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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care