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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure; Frailty; Self Care
• Intervention / Treatment: Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI)

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 Type: Interventional
• Enrollment (Anticipated): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 14186
    • Karolinska Universitetssjukhuset, Tema Inflammation och Åldrande

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self Care group; 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); 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.
No Intervention: Control group; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective physical activity	Measured with a non-invasive miniature electronic logger during 4-5 days per time frame	Baseline, 3 and 6 months
Subjective physical activity	Assessed by the instrument titled "International Physical Activity Questionnaire" (IPAQ). Measure the minutes of physical activity during a day.	Baseline, 3 and 6 months
Experiences of patients	A qualitative interview will be used to collect data on patient´s experiences of the intervention	3 months
Self-care	Assessed with the questionnaire titled "Self-care of chronic illness inventory" (30 questions). Minimum score is 28 and maximum score is 150. Higher score indicate better self care	Baseline, 3 and 6 months
Appetite	Assessed with the questionnaire titled "The Council on Nutrition Appetite Questionnaire" (8 questions)Failure". Minimum score is 8 and maximum score is 40. Higher score indicate better appetite	Baseline, 3 and 6 months
Thirst distress	Assessed with the questionnaire titled "Thirst Distress Scale for patients with Heart Failure" (8 questions) Minimum score is 8 and maximum score is 40. Higher score indicate higher thirst distress	Baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Nana Waldréus, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: exercise; nutrition; heart failure; symptom management; self care
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Heart Failure; Frailty
• Other Study ID Numbers: Dnr 2020-00295

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No