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Self CareSOPHINCT05009706

Self-care in Older Frail Persons With Heart Failure Intervention

A study testing Self-care in Older frail Persons with Heart failure Intervention (SOPHI) in people with Self Care and Heart Failure, run by Karolinska Institutet at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Self Care, Heart Failure, Frailty
What is being tested?
Self-care in Older frail Persons with Heart failure Intervention (SOPHI)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteSweden
Study dates
6 Sep 2021to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Universitetssjukhuset, Tema Inflammation och Åldrande

    Huddinge, 14186

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Self-care in Older frail Persons with Heart failure Intervention (SOPHI)
Keywords
self care, heart failure, symptom management, exercise, nutrition
Medical subject headings
Heart Failure, Frailty, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT05009706
Study groupRoleWhat they receive
Self Care groupExperimentalPatients 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.
Receives: Other: Self-care in Older frail Persons with Heart failure Intervention (SOPHI)
Control groupNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (11)

  1. 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).

    Measured: Baseline, 3 and 6 months

  2. 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

    Measured: Baseline, 3 and 6 months

  3. Aerobic capacity/endurance

    Assessed with the 6-minute walk test, the distance in meters covered over a time of 6 minutes

    Measured: Baseline, 3 and 6 months

  4. 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

    Measured: Baseline, 3 and 6 months

  5. 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

    Measured: Baseline, 3 and 6 months

  6. Hand strength

    Assessed with the hand-gripdynamometer (JAMAR)

    Measured: Baseline, 3 and 6 months

  7. Hospital readmissions

    The number of hospital readmissions during a 12 month period will be retrieved from the patients medical record

    Measured: 12 months

  8. Lower body strength

    Sit to stand test measure the number of uprising from a chair during 30 seconds

    Measured: Baseline, 3 and 6 months

  9. 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

    Measured: Baseline, 3 and 6 months

  10. Inflammation marker

    Plasma C-reactive protein (mg/L), reference interval value below 3 mg/L. Higher value indicate inflammation in the body

    Measured: Baseline, 3 and 6 months

  11. Sarcopenia

    Measured by the criteria of European Working Group on Sarcopenia in Older People's

    Measured: Baseline, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start6 Sep 2021
  3. Primary completionSep 2024 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009706
Sponsor's protocol ID
Dnr 2020-00295
Acronym
SOPHI
Status last verified
Mar 2022
First submitted
4 Aug 2021
Last updated
7 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-care in Older frail Persons with Heart failure Intervention (SOPHI) in people with Self Care and Heart Failure, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical performance (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05009706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.

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