Self-care in Older Frail Persons With Heart Failure Intervention (SOPHI)

Karolinska Institute

Status: Invitation-only

Conditions: Self Care; Frailty; Heart Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05009706

Dnr 2020-00295

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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212 participants in 2 patient groups

Self Care group

Experimental group

Description:

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.

Treatment:

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

Control group

No Intervention group

Description:

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.