Holly Health for hypertension and mental health v1.1
Research type
Research Study
Full title
Holly Health: A feasibility randomised controlled trial of a personalised, scalable health coaching intervention for patients living with hypertension, anxiety and/or depression
IRAS ID
333701
Contact name
Daniela Mercado Beivide
Contact email
Sponsor organisation
Holly Health
ISRCTN Number
ISRCTN14391408
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
Summary of Research
Chronic disease rates including high blood pressure, are rising and leading to expensive and often avoidable cardiovascular health events. Notably, over 30% of hypertension patients are affected by anxiety/depression, impacting their ability to manage lifestyle behaviours consistently. Holly Health, an established personalised digital coaching platform (which has supported 25,000 people so far) with health behaviour changes, will run a randomised controlled clinical trial (using a waitlist control) with patients living with hypertension and depression/anxiety and who are registered in Northumbria Primary Care.
The goal of this project is to establish the feasibility and acceptability of providing a digital health coach service by assessing recruitment, engagement, retention rates and feedback. We will also measure changes in health behaviours, personal wellbeing and blood pressure readings before and after engaging with the service.
Participants will have an in-person visit with a member of staff from the practice to do an initial assessment including some questionnaires and a blood pressure reading. After that, participants randomly allocated to the intervention will get access to the digital health coaching service (Holly Health) and will go through a ‘behavioural health check’ with a chatbot (I.e., the Holly bird) covering physical and mental health questions that will inform their digital coaching experience. The service will provide ongoing motivational coaching messages, educational content, self-reflection exercises and in-the-moment support. Participants will also have the option to track their blood pressure, daily mood and energy levels. 12 weeks later, participants will do a second visit to the GP practice for a post-assessment session. Waitlist participants will be given access to Holly Health after this point.
Participants will have unlimited access to the Holly Health app for 12 months. However, the last assessment point will be at 6 months from baseline
Summary of Results
Primary feasibility outcomes:
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.Feasibility: Recruitment was completed within a pre-defined timeframe (May-November 2024). For baseline characteristics, see Table 1; for patient flow through the study, see Fig 2 (CONSORT diagram): https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.isrctn.com%252Feditorial%252FretrieveFile%252F8d9e98f9-b089-4991-a063-32af81a1726c%252F44712.%2FNBTI%2F_wDDAQ%2FAQ%2F3a5a30a8-be75-41bb-a3f2-63ef9cbc3a5a%2F2%2FS1eB5XHgsT&data=05%7C02%7Capprovals%40hra.nhs.uk%7Cead4932bc2674839f10608de5dc0d7b1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639051280025884616%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=L3dqtwE%2BV5rQ8dXN%2Be4%2FGME%2FODcMWl97ryjosqyO%2BOI%3D&reserved=0
101 people were screened for eligibility and 46 randomised people attended their baseline assessment (Control n = 25, Active n = 21). Study retention rates from baseline to post-intervention were 74% (34/46).Usefulness and acceptability: 92% found it acceptable as a potential complementary treatment, and 65% of participants found Holly Health useful during the study period.
Perceived benefit: 92% of participants would recommend Holly Health to others, and 69% felt they benefited from the service.
Qualitative feedback: Out of 13 participants in the active group, 9 of them provided positive feedback regarding their experience using Holly Health (69%), 2 reported neutral feedback (15%) and 2 reported negative feedback (15%).
Secondary outcomes:
Health outcomes: At 12 weeks, change scores for 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.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). Additionally, 77.8% of participants reported doing their healthy habits automatically after 8 weeks of Holly Health use.
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).
REC name
East of Scotland Research Ethics Service REC 2
REC reference
24/ES/0012
Date of REC Opinion
20 Feb 2024
REC opinion
Further Information Favourable Opinion