Effects of person-centred care using a digital platform and structured telephone support for people with chronic obstructive pulmonary disease and chronic heart failure: randomised controlled trial

Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) are associated with high rehospitalisation rates. Self-management strategies are essential to optimise outcomes and prevent hospitalisation. Person-centred care (PCC) is known to be beneficial for patients with COPD and/or CHF but it has not yet been investigated through e-health services.

The aim of this study was to investigate PCC using a combined digital platform and telephone support for people with COPD and/or CHF.

This is the first randomised control trial to investigate PCC using a combined digital platform and structured telephone support. These e-health interventions appear to increase the short-term self-efficacy of people with COPD and CHF.

A PCC e-health platform could be used as add on treatment to usual care in primary care in the management of people with COPD and CHF.

The Person-centred Care at Distance (PROTECT) study (NCT03183817) was a randomised clinical study that recruited participants from 9 primary health centres in Gothenburg. Patients (n=224) were randomly assigned to either standard care or PCC in addition to standard care, for 6 months. The structured telephone support program involved a health plan created by both patients and healthcare providers. The digital platform involved access to shared documentation (health plans and self-ratings) and reliable information sources. Data were collected through questionnaires and from medical records at baseline, 3 and 6 months. A patient was classified as improved if they reported an increase of ≥5 on the General Self-Efficacy (GSE) Scale, the patient was alive and not hospitalised because of COPD or CHF. A patient was classified as deteriorated if GSE decreased by ≥5 units, the patient died of any cause or underwent unscheduled hospitalisation due to COPD or CHF.

• A composite of GSE changes and hospitalisation or death, 6 months after randomisation into each group.

• National registration within the Västra Götaland Region (VGR)
• Listed at a primary care centre in Närhälsan with a history of confirmed diagnosis of COPD and /or CHF
• Must understand written and spoken Swedish

• Severe impairment (cognitive or other) that prevents patient from using the e-health support
• Any severe disease with an expected survival <12 months
• Cognitive impairment (SPMSQ score >6)

• At 3- and 6-month follow up, there were no significant differences in composite scores (improved vs. deteriorated or unchanged) between the groups
• There was a significant difference in the per protocol (PP) analysis at the 3-month follow-up (p=0.047) but these differences were not sustained at 6 months.
• Differences were largely due to improvements on the GSE scale. The PP group had a mean improvement of 0.941 points, whereas the control group had a mean reduction of 0.568 points (p=0.03).
• At 3 months, 19.2% of the PP group vs. 8.9% of the control group had an improvement of ≥5 points on the GSE scale, i.e. the PP group was more than twice as likely to have a clinically meaningful improvement in GSE compared with the control group
• There were no differences in composite scores between patients with COPD, CHF, or COPD and CHF

A 6-month intervention with PCC using a combined digital platform and structured telephone support did not improve outcomes in terms of composite end point of change on the GSE score and absence of hospitalisation or death. However, the PP analysis, which only included those who used the intervention, showed a difference in composite scores at 3 months. One reason for the lack of significant difference in the intention-to-treat group was that the participants had relatively stable disease.

• There were few hospitalisation events; a different outcome measure might have been more suitable for this study population
• The participants had a high mean GSE score at baseline, leaving little scope for improvement
• A more rigorous screening procedure might have identified patients more likely to benefit from the intervention