HARMONY
Feasibility Trial

HARMONY

A shared decision-making dashboard for fluid management in haemodialysis.

A transnational feasibility trial (Austria, Ireland, Scotland) integrating routinely collected dialysis data with patient-reported symptoms to enable patient-centred fluid management decisions.

Sign in to the dashboard

Study Rationale

Fluid status in haemodialysis is strongly associated with acute symptoms, hospitalisation, and cardiovascular mortality. Despite technological advances, routine fluid management practice — target weight estimation and interdialytic weight gain control — has changed little in decades. HARMONY frames fluid management as a complex intervention requiring systems-level support: integrating routinely collected dialysis data with patient-reported symptoms to enable truly shared, patient-centred decisions. The intervention design is underpinned by Social Cognitive Theory, drawing on established behaviour-change mechanisms related to self-efficacy, feedback, and shared decision-making.

Study Objectives

Primary Objective

To assess the feasibility of conducting a pragmatic, multicentre, cluster randomised trial of data-enabled shared decision-making for fluid management in haemodialysis.

Secondary Objectives

  • i.Estimate signals of effect on intradialytic hypotension
  • ii.Characterise adherence to the platform by patients and clinicians
  • iii.Describe data completeness and process metrics to refine the intervention and trial procedures
  • iv.Assess quality of life status
  • v.Evaluate shared decision-making (NICE framework survey)

Platform Interface

Patient and clinician views designed for use at the dialysis chair.

harmony.study/patient

HARMONY Study · Week 3/12

Hello, HMY-0042!

Today: Arrival

💧 How do you feel today?

General wellbeing / fluid balance

1
2
3
4
5

🥤 How strong is your thirst?

1
2
3
4
5

⚖️ Do you feel fluid overloaded?

1
2
3
4
5

⏱️ How long did your recovery after dialysis take?

Time until you felt recovered after the last session

0–2 h
3–6 h
7–12 h
>12 h
Save
harmony.study/provider

MWF Morning · Week 3

Shift Dashboard

8 / 12 PROMs

HMY-0042

231
Edit PROM
Feldbach·14 sessions

HMY-0017

443
Edit PROM
Feldbach·13 sessions

HMY-0091

Enter PROM
Feldbach·11 sessionsLast PROM: 9d

HMY-0055

Enter PROM
Feldbach·12 sessions

Study Design

Prospective, multicentre, cluster randomised, open-label, waitlist-controlled feasibility trial. Clusters (dialysis centres) are randomised 1:1 to intervention or waitlist control. Centres randomised to intervention receive 12 weeks of exposure to the fluid dashboard web application. Control centres receive standard of care for 12 weeks before crossing over to the intervention. The waitlist-controlled design minimises contamination between clinicians and patients while ensuring all centres ultimately receive the platform.

Patient-Reported Outcomes

Patients log fluid status, thirst, and recovery time at every session via a simple large-touch interface.

Clinical Monitoring

Nursing staff enter weight, IDWG, and blood pressure. Trend charts support clinical decision-making.

Feasibility Tracking

Study coordinators monitor participation rates, data completeness, and PROM trends across the 12-week period.