A feasibility randomised controlled trial (RCT) of a personalised, scalable health coaching intervention for patients living with hypertension, anxiety and/or depression

Background

Hypertension affects over 19 million adults in the UK and is a major risk factor for cardiovascular disease (NICE, 2023). The good news is that it can be prevented (and better managed) through behaviours including changes to nutrition and exercise, as well as stress reduction and mood management (Nyberg et al., 2020). In addition, hypertension often co-occurs with mental health challenges, around 30% of people with hypertension also meet the diagnosis threshold for depression/anxiety) (Zhanzhan Li, 2015) making health self-management even more challenging (Lovett, 2020). However, in the current care pathway, there is a lack of support available for physical and mental health simultaneously. ‍

To address this challenge, this study aimed to investigate the feasibility and acceptability of providing a fully digital health coaching solution to patients with hypertension and co-morbidities of anxiety and depression.

The Innovation

Holly Health is an NHS-approved, personalised digital coaching service that integrates intelligent, adaptive, engaging support across key physical and mental health behaviours for full-population access and scalability. With promising results in general wellbeing and behaviour change, and with design input from existing >200 GP practice partners, this Innovate UK-funded project aimed to provide a cost-effective personalised behaviour change support to people with hypertension and mental health challenges at a national level that can result in better health outcomes through increased self-management abilities and a reduction of associated NHS costs. 

Aims 

This RCT in collaboration with Northumbria Primary Care aimed to establish the feasibility and acceptability of providing a digital health coach service to primary care patients living with hypertension and depression/anxiety by assessing recruitment, engagement, retention rates and qualitative feedback. The secondary aim was to measure changes in health behaviours, personal wellbeing and blood pressure readings before and after engaging with the service. As an exploratory analysis, the study looked into changes in GP appointments and prescriptions after using Holly Health for six months.

Methods and Participants 

This study was a randomised controlled trial comparing the delivery of a digital health coaching intervention Holly Health for 12 weeks, versus a waiting list control.

- Control group: n= 21 (52% male, 48% female)

- Active group: n= 13 (46% male, 54% female) 

Key Findings 

1. Feasibility: The study is feasible as we recruited the minimum sample size in the allocated timeframe (sample size of 12 per group, rule of thumb for a pilot study). 

2. Usefulness and acceptability: 92% found it acceptable as a potential complementary treatment, and 65% of participants found Holly Health useful during the study period.

3. Perceived benefit: 92% of participants would recommend Holly Health to others, and 69% felt they benefited from the service.

4. Qualitative feedback:

Positive: 

• “I find it a very useful easy to use app. It helped me get into better habits and remember to do exercises, drink water etc. Also Discovery - exercises and videos were helpful“
• “Any assistance in stopping and taking time to consider your mental health + general wellbeing has to be good for you. The timely reminder were especially helpful for me“
• “Makes you think about mindfullness and how it affects you and your mental health"

Constructive: 

• “The answers to my questions, the answers [were too] fast at showing in the app“
• “Lacked guidance and instructions and how to use the app at the start“

5. Health outcomes: At 12 weeks, blood pressure readings, DASS and GP appointments looked similar in both groups. Waist circumference and volume of medications dispatched were better in the Holly Health group compared to control.

6. Behavioural outcomes (Holly Health group only): Self-reported improvements after 8 weeks of engaging with the Holly Health app of up to 27% across physical and mental health markers including: 19% average improvement in personal wellbeing (measured by ONS-4), 19% improvement in alcohol drinking frequency, and 15% improvement in exercise (including moderate cardiovascular exercise, strength and flexibility-based exercise). 

7. GP appointments and medication dispatches: Data from the medical records of participants who onboarded (i.e., active group plus participants in the control group who chose to download the HH app after the waiting period, n=28) showed an average reduction of 1.43 fewer GP appointments per person six months after baseline assessment compared to 6 months before the study started. For reference, there was no change in the number of appointments for those in the control group who did not onboard to the HH app after the waiting period. However, this group is very small (n=6). The number of medications dispatched 6 months after the initial assessment compared to 6 months before increased across groups. However, for those who onboarded to the HH app, the increase was smaller than in those who did not (6.8 vs 10.8 more medications dispatched).

Conclusion

This study suggests that conducting a larger-scale randomised controlled trial using Holly Health as a self-management tool for primary care patients with hypertension and depression/anxiety is feasible and acceptable. The fully digital nature of the trial engagement reflects the real-world use of the service which provides more accurate insights into the potential impact of the intervention. However, retention rates can be improved by offering more time flexibility for in-person baseline and follow-up assessments. Qualitative feedback both from written forms and semi-structured interviews suggests that patients found value in the Holly Health service and also highlights areas of improvement to increase accessibility and improve user experience. Longer-term data from a 6-month follow-up provided further insights into the potential of a fully digital self-management tool to impact NHS primary care services, mainly by reducing GP appointments. This feasibility trial was the first step towards gathering the highest-quality evidence to support the use of digital health interventions for physical and mental health across different populations. 

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Read more about our science and research at: hollyhealth.io/science-research

For research collaboration opportunities, contact the team at: hello@hollyhealth.io