Self-care in Older Frail Persons With Heart Failure Intervention

Study Overview
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Brief Summary
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The overall purpose of the randomized controlled study is to evaluate the effects of physical exercise, nutrition and symptom management on physical capacity in older, frail persons with heart failure.

Detailed Description
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The randomized controlled study will be conducted in order to evaluate the effects of individual needs of physical exercise, nutrition, and symptom management in patients with heart failure who are frail and older. Patients discharged from a geriatric hospital will be recruited and included after informed consent. Two weeks after hospital discharge patients are randomized to intervention or control group. The intervention period is 3 months. With support from a physioterapeut, dietician and a registered nurse, the intervention will be performed in the participants´ home. Once a week participants will come to the hospital for physical exercise led by a physiotherapist. Once a week or every other week participants will meet a dietician and a nurse. Data will be collected at baseline, and 3 and 6 months after baseline. Data consist of e.g. study flow description, number of eligible patients, number of drop-outs, patients sociodemographic- and clinical data, physical function and performance, nutritional status, symptom burden, self-care, appetite, thirst, health-related quality of life. At 12 months after baseline, data will be collected on hospital admissions, reasons for hospital admissions, length of stay and mortality.

Official Title
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Self-care in Older Frail Persons With Heart Failure Intervention (SOPHI). Individualized Physical Exercise, Diet and Symptom Management- A Randomized Controlled Trial.

Conditions
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Self Care, Heart Failure, Frailty

Intervention / Treatment
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* Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at geriatric clinic Diagnosed with heart failure (independent of Ejection Fraction (EF): both patients with preserved EF or reduced EF can be included New York Heart Association functional class II - III Clinical frailty level 4-6 (moderate frailty) Discharge from hospital to home Exclusion Criteria: New York Heart Associacion functional class I or IV Clinical frailty level 1-3 (no/mild frailty) and 7-9 (severe frailty) The patient is unable to perform gait tests due to visual (see a TV screen at a 3 meter distance), cognitive (assessed by nurse or doctor) or motor impairment (the patient should be able to stand up from sitting and have the ability to walk with or without a walker or other walking aid). The patient is unable to follow instructions (assessed by nurse or doctor)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self Care group<br>Patients who are randomized to the intervention Self Care group will get advice and support on physical excercise, nutrition and symptom management to perform at home for 12 weeks. Once a week, patients will come to the hospital for follow-up and to exercise with a physiotherapist. | Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI)<br>* Patients who are randomized to the Self Care group will receive oral and written information, advice and support on following activities: excercise (from physiotherapist), nutrition (dietician) and symptom management (nurse), based on patient´s individual needs and abilities. The Self Care group will perform the activities daily at home. Once a week, patients come to the hospital to exercise with the support of a physiotherapist. Once a week or every other week patients will meet (at hospital or by phone) the dietician and nurse to solve possible problems and to follow-up food/nutrition intake and symptoms/symptom management.<br>|
| No Intervention: Control group<br>Patients who are randomized to the Control group will receive ordinary health care (from an outpatient clinic), but will also be encouraged to follow recommendation of 150 minutes/week of moderate physical activity (12 weeks). To compensate for the extra attention received by the intervention group by the advice/support, the patients in the control group will be dialed with a nurse at 3, 6 and 9 weeks to discuss their current activity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical performance | The Short Physical Performance Battery is composed of standing balance, gait speed, and timed repeated chair rise. The total score range from minimum 0 to maximum 12, with higher scores indicating better physical performance. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden | Assessed by the questionnaire titled The Memorial Symptom Assessment Scale- Heart Failure, that evaluates symptoms experienced by the patient in the last week (a total of 36 symptoms, for example pain, nausea, tiredness). A score of 0 is given to a symptom if it is absent. If the symptom is present, it is rated using a four-point rating scale (1-4) for frequency and severity, and a five-point rating scale (0-4) for distress of the symptom with higher scores indicating greater frequency, more severity and higher distress. For each symptom, the average of the frequency, severity and distress will be calculated to produce the outcome symptom burden (total scores ranging from minimum 0 to maximum 4, with higher scores indicating greater symptom burden). | Baseline, 3 and 6 months | 
| Health related quality of life | Assessed with the Euroqol questionnaire titled The EQ-5D. It comprises five questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answer options are no problems (score 1), moderate problems (score 2), severe/extreme problems (score 3). The results are converted into a single index value (minimum value 0 to maximum value 1). Higher value indicate better health related quality of life | Baseline, 3 and 6 months | 
| Aerobic capacity/endurance | Assessed with the 6-minute walk test, the distance in meters covered over a time of 6 minutes | Baseline, 3 and 6 months | 
| Frailty | Assessed by the scale titled Clinical Frailty Scale. From the minimum value 1 (patient is very fit) to the maximum value 9 (terminally ill). Higher score indicates more frailty | Baseline, 3 and 6 months | 
| Perceived physical effort | Assessed with the scale titled Borg Category Ratio-10 Scale of perceived exertion. The minimum value is 0 (nothing at all) to the maximum value 10 (extremely strong or maximal). Higher value indicate worse physical effort | Baseline, 3 and 6 months | 
| Hand strength | Assessed with the hand-gripdynamometer (JAMAR) | Baseline, 3 and 6 months | 
| Hospital readmissions | The number of hospital readmissions during a 12 month period will be retrieved from the patients medical record | 12 months | 
| Lower body strength | Sit to stand test measure the number of uprising from a chair during 30 seconds | Baseline, 3 and 6 months | 
| Nutrition status | Assessed by the Mini Nutritional Assessment screening. The total score range from minimum 0 to maximum 14. Higher scores indicate better nutrition status | Baseline, 3 and 6 months | 
| Inflammation marker | Plasma C-reactive protein (mg/L), reference interval value below 3 mg/L. Higher value indicate inflammation in the body | Baseline, 3 and 6 months | 
| Sarcopenia | Measured by the criteria of European Working Group on Sarcopenia in Older People's | Baseline, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self care, heart failure, symptom management, exercise, nutrition