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A pilot ranDomisEd trial of nurSe-led patIent follow-up using a diGital platform to reduce re-admissioNs after an acute presentation with Heart Failure. (DESIGN-HF)

A pilot ranDomisEd trial of nurSe-led patIent follow-up using a diGital platform to reduce re-admissioNs after an acute presentation with Heart Failure. (DESIGN-HF)

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000055101
Acronym
DESIGN-HF
Enrollment
7
Registered
2019-01-15
Start date
2019-04-16
Completion date
2019-07-25
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This research proposal will explore technologies to efficiently enhance clinical decision-making and provide interventions to the deteriorating heart failure patient at an earlier time point than standard care. It will determine if an alternate design of follow-up care utilising the “Personify Care” clinical platform can demonstrate efficiencies and in doing so decrease the substantial burden on this area of health service.

Interventions

DESIGN-HF is a randomised study to measure the usefulness of the Personify Care clinical pathway/ surveillance platform to both the patient and heart failure (HF) care team, and assess its potential impact on HF hospital readmission. Potential participants will be assessed for their ability to use a website on a digital system (eg. mobile phone, tablet, or computer) and regularity of access to such a device and internet/wifi. This will determine if participants are eligible to take part in the s

DESIGN-HF is a randomised study to measure the usefulness of the Personify Care clinical pathway/ surveillance platform to both the patient and heart failure (HF) care team, and assess its potential impact on HF hospital readmission. Potential participants will be assessed for their ability to use a website on a digital system (eg. mobile phone, tablet, or computer) and regularity of access to such a device and internet/wifi. This will determine if participants are eligible to take part in the study. The assessments conducted by Heart failure nurses (HFN) have been translated into a digital platform, PersonifyHF. After gaining informed consent, participants randomised to the intervention arm will receive a text message prompting them to register on the PersonifyHF platform. During the follow-up period participants are prompted via text messages to log in and complete assessments usually performed over the phone by a HFN. During the online assessments participants will be prompted to answer additional questions depending on answers given. This includes the additional questions the HFN asks as part of ascertaining overall status of their heart failure patient, and rephrases certain formal assessment questions in the same manner the HFN does while speaking with the patient when conducting such assessments over the phone. If certain answers to particular questions are given the participant will be prompted to take action which include calling an ambulance in the case of a life threatening emergency or to contact the HFN within a given time frame (e.g. within 2 hours). Depending on answers given in the assessment the database will flag the HFN to contact the participant within a certain time frame. The HFN will also be flagged to contact the participant if the online assessment has not been completed within 4 working days of scheduled. When the database flags a participants response the HFN will receive a text message informing them of the timeframe required to respond. The frequency of assessments are the same as standard telephone follow-up. The standard care model for HF post-discharge follow-up is based on the Australian Heart Foundation Heart Failure Clinical Guidelines. A more detailed description of the follow-up timeframes are given below. Recruited participants will be randomised 1:1 to the intervention and the standard care control: Control: Standard evidence-based transition of care nursing model; specifically: • Standard home visit 1-week post-discharge • Follow-up phone calls by nurse at 2, 4, and 6 weeks post-discharge • Follow-up phone calls by nurse at 3 and 6 months post-discharge • Nurse-initiated additional clinical care as directed by patient response, eg. investigative testing, medication adjustment, clinical appointments. Intervention: Protocolised contact and clinical care guided by nurse surveillance of patient-entered data using the Personify Care platform synergistically with the standard evidence-based transition of care nursing model; specifically: • Standard home visit 1-week post-discharge • Nurse surveillance of patient-entered data at 2, 4, and 6 weeks post-discharge • Nurse surveillance of patient-entered data at 3 and 6 months post-discharge • Nurse-initiated additional clinical care as directed by patient response, eg. investigative testing, medication adjustment, clinical appointments. Both groups: • Except for the digital platform evaluation which will be provided to the intervention group at the 6 month visit, all assessments throughout the project are as per standard HF care but via different methods for initial communication. • All participants will receive a standard, evidence-based transition of care home visit at 1 week post-discharge, regardless of study randomisation.

Sponsors

Flinders University of South Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Primary diagnosis of heart failure (HFREF or HFPEF) for whom transition of care nursing support is planned. 2. Documented ability to interact with an electronic platform and confirmed regular access to device and internet/wifi. 3. Aged >18 years

Exclusion criteria

1. Inability or unwillingness to provide informed consent. 2. Dementia or significant cognitive impairment of any cause (eg including delirium, hypoxia) as per judgement of clinical care provider(s). 3. Life-expectancy of <12 months, as determined by treating specialist. 4. Inability to understand English or sufficient visual impairment such as would be unable to understand instructions within the platform, unless sufficient reliable access to help is available eg next of kin.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026