Back to resultsSelfcare MAnagement InteRvenTion in Heart Failure II (SMART HF II)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
LifePod
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines 2016.
- Have completed the "consent form" or consent form, see §4.2 Exclusion criteria: * Patient who refuses to participate in the trial.
- It is assessed that they can handle the intervention themselves or with the help of personal or relatives.
Exclusion Criteria:
Patient who declines to participate in the trial.
- Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
- Life expectancy <8 months
- In other ways, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.
Sites / Locations
- Lund University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Intervention group
Control group
Arm Description
Standard heart failure care and a digital heart failure support system
Standard heart failure care
Outcomes
Primary Outcome Measures
Self-care behaviour
Improvement in self-care behaviour measured by the questionnaire European Heart Failure Self-care behaviour scale (EHFScB-9) A higher EHFScB-9 score indicates a worse self-care behaviour. The minimum score is 9 points and the maximum score is 45.
Cardiovascular events and deaths
Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion
Hospitalization and hospital days
Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion
Health care visits
Type and number of health care visits during intervention and up to 12 months after inclusion
Patient-reported symptoms
Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.
Quality of life
Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04327128
Brief Title
Selfcare MAnagement InteRvenTion in Heart Failure II (SMART HF II)
Official Title
Evaluation of a Digital Support and Communication Platform for Heart Failure:
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure.
To evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide:
Improved self-care
Improved quality of life and reduced number of patient-assessed symptoms
Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Standard heart failure care and a digital heart failure support system
Arm Title
Control group
Arm Type
Other
Arm Description
Standard heart failure care
Intervention Type
Device
Intervention Name(s)
LifePod
Intervention Description
The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider
Primary Outcome Measure Information:
Title
Self-care behaviour
Description
Improvement in self-care behaviour measured by the questionnaire European Heart Failure Self-care behaviour scale (EHFScB-9) A higher EHFScB-9 score indicates a worse self-care behaviour. The minimum score is 9 points and the maximum score is 45.
Time Frame
6 month
Title
Cardiovascular events and deaths
Description
Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion
Time Frame
12 month
Title
Hospitalization and hospital days
Description
Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion
Time Frame
12 months
Title
Health care visits
Description
Type and number of health care visits during intervention and up to 12 months after inclusion
Time Frame
12 months
Title
Patient-reported symptoms
Description
Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.
Time Frame
6 months
Title
Quality of life
Description
Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines 2016.
Have completed the "consent form" or consent form, see §4.2 Exclusion criteria: * Patient who refuses to participate in the trial.
It is assessed that they can handle the intervention themselves or with the help of personal or relatives.
Exclusion Criteria:
Patient who declines to participate in the trial.
Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
Life expectancy <8 months
In other ways, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Gerward, MD, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University
City
Lund
State/Province
Skåne
ZIP/Postal Code
22100
Country
Sweden
12. IPD Sharing Statement
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Selfcare MAnagement InteRvenTion in Heart Failure II (SMART HF II)
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