Patient-centred Home-based Management of Heart Failure
PACEMAN-HF
1 other identifier
interventional
82
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 heart-failure
Started Feb 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2013
CompletedFirst Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedSeptember 4, 2018
August 1, 2018
10 months
August 30, 2018
August 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
In-hospital days due to heart failure
6 months
Quality of life (general)
6 months
Quality of life (disease-specific)
6 months
Knowledge about heart failure
6 months
Study Arms (2)
Control group
NO INTERVENTIONSubject to standard care.
Intervention group
EXPERIMENTALExposed to the home-based tool.
Interventions
The tool consists of a tablet computer and a Bluetooth connected weight scale. The patient is encouraged to use the tool daily. The weight is titrates the dose of diuretics and a short tip about how to improve living with heart failure, this is presented on the screen. Every five days the patient assess their self-perceived symptoms on the tablet computer. If the weight increases by 2kg or more in 3 days or less, the high dose is recommended for two days, after which the effect on the weight is assessed. If the weight increased was reverted, the dose is returned to normal and if it is still elevated, an alert on the table computer. If the self-assessed symptoms deteriorate, the same type of alert will appear on screen, urging the patient to contact the health care provider.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CareLigo ABlead
- Karolinska University Hospitalcollaborator
- Danderyd's hospitalcollaborator
- Stockholm South General Hospitalcollaborator
Related Publications (3)
Hagglund E, Lynga 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.
PMID: 25968968BACKGROUNDMelin M, Hagglund 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.
PMID: 29369123BACKGROUNDHovland-Tanneryd A, Melin M, Hagglund E, Hagerman I, Persson HE. From randomised controlled trial to real world implementation of a novel home-based heart failure tool: pooled and comparative analyses of two clinical controlled trials. Open Heart. 2019 May 28;6(1):e000954. doi: 10.1136/openhrt-2018-000954. eCollection 2019.
PMID: 31217992DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inger Hagerman, PhD
Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2018
First Posted
August 31, 2018
Study Start
February 22, 2013
Primary Completion
December 18, 2013
Study Completion
December 18, 2013
Last Updated
September 4, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share