Heart Failure Clinical Trial
— PACEMAN-HFOfficial title:
Patient-centred Home-based Management of Heart Failure
Verified date | August 2018 |
Source | CareLigo AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A novel home-based tool for self-management is to be evaluated for heart failure patients. The tool assists the patient with symptom monitoring, education and titration of diuretics. Patients who were recently hospitalized for heart failure will be randomized to receiving the tool or standard care for six months. The primary end-point will be self-care behaviour, as measured with the validated instrument the European Heart failure self-care behaviour Scale 9-item questionnaire (Jaarsma et al). Secondary end-points are in-hospital days due to heart failure, quality of life (general and disease-specific) as measured by the SF-36 and KCCQ questionnaires, and finally knowledge about heart failure, assessed by the Dutch Heart Failure Knowledge Scale.
Status | Completed |
Enrollment | 82 |
Est. completion date | December 18, 2013 |
Est. primary completion date | December 18, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - admitted due to acute heart failure - diagnosed heart failure according to European Society of Cardiology (ESC) guidelines 2012 - prescribed loop-diuretics - Signed letter of consent Exclusion Criteria: - more than mild cognitive impairment - pregnancy - having attended nurse-led heart failure clinic the past 12 months, or referred to one following this current hospitalization - life-expectancy of less than 6 months |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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CareLigo AB | Danderyd's hospital, Karolinska University Hospital, Stockholm South General Hospital |
Hägglund E, Lyngå P, Frie F, Ullman B, Persson H, Melin M, Hagerman I. Patient-centred home-based management of heart failure. Findings from a randomised clinical trial evaluating a tablet computer for self-care, quality of life and effects on knowledge. Scand Cardiovasc J. 2015 Aug;49(4):193-9. doi: 10.3109/14017431.2015.1035319. Epub 2015 Jun 4. — View Citation
Melin M, Hägglund E, Ullman B, Persson H, Hagerman I. Effects of a Tablet Computer on Self-care, Quality of Life, and Knowledge: A Randomized Clinical Trial. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):336-343. doi: 10.1097/JCN.0000000000000462. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-care behaviour | Assessed by the validated instrument European Heart Failure Self-care Behaviour Scale. It measures how well the patient adheres to advice provided from the health care professional. It si made up of nine questions to which the patient answers between "completely agree" and "completely disagree", corresponding to a score of 1 or 5 respectively. The possible scores on the questionnaire range from 9 to 45, where 9 corresponds to the most desireable self-care behaviour and 45 to the least favourable. | 6 months | |
Secondary | In-hospital days due to heart failure | Data retrieved from the medical records after the intervention period is completed. All hospitalizations analyzed and adjudicated as either heart failure related or not. | 6 months | |
Secondary | Quality of life (general) | Assessed by the 36-item Short Form survey (SF-36). The instrument includes 8 multi-item scales plus a single-item scale to compare the patient's current health with that 1 year ago. The 8 domains are physical functioning, physical role, bodily pain, general health vitality, social functioning, role of emotional health and role of mental health. SF-36 also consists of two summary scores: mental and physical. The scores range from 0 to 100 and higher scores indicate better quality of life. | 6 months | |
Secondary | Quality of life (disease-specific) | Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 23-item (15 questions), self-administrating,disease-specifi c instrument that quantifi es 6 domains (scales) and 2 summary scores of patients' health status. The 6 domains are physical limitations, symptom score, symptom change, self-effi cacy, social interference and QoL. The 2 summary scores are labelled: clinical summary scores and overall summary scores. All scale scores are transformed to 0 - 100 scale, in which a higher score indicates better health related quality of life (HRQoL). | 6 months | |
Secondary | Knowledge about heart failure | Assessed by the Dutch Heart Failure Knowledge Scale (DHFKS), which consists of 15 multiple-choice items (0 - 15). It measures knowledge in HF in general, symptom recognition and treatment. Higher scores indicate more knowledge. | 6 months |
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