Self-care in Older Frail Persons With Heart Failure Intervention

Not Applicable

• Conditions: Heart Failure; Frailty; Self Care
• Interventions: Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI)

• Registration Number: NCT05009706
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-17
• Study Start: 2021-09-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07
• Primary Completion: 2024-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 212

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self Care group	Self-care in Older frail Persons with Heart failure Intervention (SOPHI)	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.

Primary Outcome Measures

Name	Time	Method
Change in physical performance	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Perceived physical effort	Baseline, 3 and 6 months	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
Aerobic capacity/endurance	Baseline, 3 and 6 months	Assessed with the 6-minute walk test, the distance in meters covered over a time of 6 minutes
Frailty	Baseline, 3 and 6 months	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
Hand strength	Baseline, 3 and 6 months	Assessed with the hand-gripdynamometer (JAMAR)
Sarcopenia	Baseline, 3 and 6 months	Measured by the criteria of European Working Group on Sarcopenia in Older People's
Symptom burden	Baseline, 3 and 6 months	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).
Lower body strength	Baseline, 3 and 6 months	Sit to stand test measure the number of uprising from a chair during 30 seconds
Inflammation marker	Baseline, 3 and 6 months	Plasma C-reactive protein (mg/L), reference interval value below 3 mg/L. Higher value indicate inflammation in the body
Health related quality of life	Baseline, 3 and 6 months	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
Hospital readmissions	12 months	The number of hospital readmissions during a 12 month period will be retrieved from the patients medical record
Nutrition status	Baseline, 3 and 6 months	Assessed by the "Mini Nutritional Assessment" screening. The total score range from minimum 0 to maximum 14. Higher scores indicate better nutrition status

Trial Locations

Locations (1)

Karolinska Universitetssjukhuset, Tema Inflammation och Åldrande; 🇸🇪 Huddinge, Sweden