1 Recommendations

Can be used with evidence generation

1.1

Six digital technologies can be used in the NHS during the evidence generation period as options to support cardiac rehabilitation for adults with cardiovascular disease (CVD). The technologies are:

Activate Your Heart
D REACH-HF
Digital Heart Manual
Gro Health HeartBuddy
KiActiv
myHeart.

These technologies can only be used:
after a trained healthcare professional has assessed that the technology is suitable for the person having cardiac rehabilitation
if the evidence outlined in the evidence generation plan for these technologies is being generated
as long as they have appropriate regulatory approval including NHS England's Digital Technology Assessment Criteria (DTAC) approval.

1.2

The companies must confirm that agreements are in place to generate the evidence. They should contact NICE annually to confirm that evidence is being generated and analysed as planned. NICE may revise or withdraw the guidance if these conditions are not met.

1.3

At the end of the evidence generation period (3 years), the companies should submit the evidence to NICE in a format that can be used for decision making. NICE will review the evidence and assess if the technology can be routinely adopted in the NHS.

More research is needed

1.4

More research is needed on 7 digital technologies to support cardiac rehabilitation for adults with CVD before they can be funded by the NHS. The technologies are:

Beat Better
Datos Health
Get Ready
Luscii vitals
Pumping Marvellous Cardiac Rehab Platform
R Plus Health
Sword Move.

What this means in practice Can be used with evidence generation The 6 technologies in recommendation 1.1 can be used as an option in the NHS during the evidence generation period (3 years) and paid for using core NHS funding. During this time, more evidence will be collected to address any uncertainties. Companies are responsible for organising funding for evidence generation activities. After this, NICE will review this guidance, and the recommendations may change. Take this into account when negotiating the length of contracts and licence costs. Potential benefits of use in the NHS with evidence generation Access: Access to and uptake of cardiac rehabilitation is limited across the NHS. Digital technologies to support cardiac rehabilitation may help improve access, uptake and adherence for people who may not be able to or may be less inclined to attend in-person cardiac rehabilitation sessions. For example, people with work or caring responsibilities, people living in rural communities with long travel times to clinics, or people who feel that the current in-person offering is not suited to their needs. System benefit: Increasing the number of people who use cardiac rehabilitation programmes could reduce secondary cardiovascular events and unplanned hospital admissions. Clinical benefit: Clinical evidence suggests that these digital technologies may improve the exercise capacity, cardiovascular risk profile, health-related quality of life and psychological wellbeing of people with CVD. Resources: Increasing the number of people who do cardiac rehabilitation is likely to use fewer resources if digital tools are used compared with conventional cardiac rehabilitation. Equality: Offering digital technologies could increase flexibility so that patient preferences, needs and commitments can be accommodated better. Managing the risk of use in the NHS with evidence generation Costs: Early economic modelling suggests that the technologies could be cost effective, but the results are uncertain. This guidance will be reviewed after 3 years and the recommendations may change. Trusts should take into account the costs of the digital technologies in this evaluation when implementing the technologies. When negotiating with companies, trusts should also consider the upfront costs for implementing a technology, staff and patient training, integration with NHS systems, and providing smart devices. Clinical risk: Evidence comparing digital technologies with conventional cardiac rehabilitation is limited and the results are uncertain. When deciding whether to do digital or conventional cardiac rehabilitation, healthcare professionals and people with CVD should consider how likely it is that digital technologies will have similar effectiveness to conventional cardiac rehabilitation for that person. Clinical subgroups: There is no evidence to show whether digital technologies to support cardiac rehabilitation are clinically effective in particular subgroups. CVD risk is higher in older people, people in more deprived areas and in certain ethnic groups. Incidence of CVD is increasing in younger people. Uptake of cardiac rehabilitation is low among women, people from more deprived areas and people from ethnic minority groups. It is uncertain whether the digital technologies are as effective in these subgroups as in the general CVD population. Clinical assessment: A trained NHS healthcare professional should do a full clinical assessment before offering these technologies to make sure they are suitable for the person with CVD. Referral to these services should be in line with national and local guidelines. Some people may choose not to use a digital service and may prefer another treatment option. Everyone has the right to make informed decisions about their care (see the NICE guideline for shared decision making). Resources: Implementing digital technologies for cardiac rehabilitation could lead to an increase in the number of people doing cardiac rehabilitation and the number of appointments for assessments. Also, staff may have to spend time training patients to use digital tools. Equality: There is a risk that using digital technologies could widen the gap in access to cardiac rehabilitation. There are groups of people who may struggle to use digitally supported cardiac rehabilitation, such as people who are less comfortable or skilled in using digital technology, people who have limited access to equipment and the internet, people who are experiencing homelessness, and people living in homes of multiple occupancy or in residential care. Additional support may be needed for people who have visual, hearing or cognitive impairment, reduced manual dexterity or a learning disability, people who do not have English as a first language or understand health-related information. People's cultural, ethnic or religious backgrounds may affect how cardiac rehabilitation should be delivered. These people should be supported through shared decision making to select the appropriate treatment option for them and may need additional support. More research is needed
There is not enough evidence to support funding in the NHS for the 7 technologies listed in recommendation 1.4. Access to technologies should be through company, research or non-core NHS funding, and clinical or financial risks should be managed appropriately.

What this means in practice

Can be used with evidence generation

The 6 technologies in recommendation 1.1 can be used as an option in the NHS during the evidence generation period (3 years) and paid for using core NHS funding. During this time, more evidence will be collected to address any uncertainties. Companies are responsible for organising funding for evidence generation activities.

After this, NICE will review this guidance, and the recommendations may change. Take this into account when negotiating the length of contracts and licence costs.

Potential benefits of use in the NHS with evidence generation

Access: Access to and uptake of cardiac rehabilitation is limited across the NHS. Digital technologies to support cardiac rehabilitation may help improve access, uptake and adherence for people who may not be able to or may be less inclined to attend in-person cardiac rehabilitation sessions. For example, people with work or caring responsibilities, people living in rural communities with long travel times to clinics, or people who feel that the current in-person offering is not suited to their needs.
System benefit: Increasing the number of people who use cardiac rehabilitation programmes could reduce secondary cardiovascular events and unplanned hospital admissions.
Clinical benefit: Clinical evidence suggests that these digital technologies may improve the exercise capacity, cardiovascular risk profile, health-related quality of life and psychological wellbeing of people with CVD.
Resources: Increasing the number of people who do cardiac rehabilitation is likely to use fewer resources if digital tools are used compared with conventional cardiac rehabilitation.
Equality: Offering digital technologies could increase flexibility so that patient preferences, needs and commitments can be accommodated better.

Managing the risk of use in the NHS with evidence generation

Costs: Early economic modelling suggests that the technologies could be cost effective, but the results are uncertain. This guidance will be reviewed after 3 years and the recommendations may change. Trusts should take into account the costs of the digital technologies in this evaluation when implementing the technologies. When negotiating with companies, trusts should also consider the upfront costs for implementing a technology, staff and patient training, integration with NHS systems, and providing smart devices.
Clinical risk: Evidence comparing digital technologies with conventional cardiac rehabilitation is limited and the results are uncertain. When deciding whether to do digital or conventional cardiac rehabilitation, healthcare professionals and people with CVD should consider how likely it is that digital technologies will have similar effectiveness to conventional cardiac rehabilitation for that person.
Clinical subgroups: There is no evidence to show whether digital technologies to support cardiac rehabilitation are clinically effective in particular subgroups. CVD risk is higher in older people, people in more deprived areas and in certain ethnic groups. Incidence of CVD is increasing in younger people. Uptake of cardiac rehabilitation is low among women, people from more deprived areas and people from ethnic minority groups. It is uncertain whether the digital technologies are as effective in these subgroups as in the general CVD population.
Clinical assessment: A trained NHS healthcare professional should do a full clinical assessment before offering these technologies to make sure they are suitable for the person with CVD. Referral to these services should be in line with national and local guidelines. Some people may choose not to use a digital service and may prefer another treatment option. Everyone has the right to make informed decisions about their care (see the NICE guideline for shared decision making).
Resources: Implementing digital technologies for cardiac rehabilitation could lead to an increase in the number of people doing cardiac rehabilitation and the number of appointments for assessments. Also, staff may have to spend time training patients to use digital tools.
Equality: There is a risk that using digital technologies could widen the gap in access to cardiac rehabilitation. There are groups of people who may struggle to use digitally supported cardiac rehabilitation, such as people who are less comfortable or skilled in using digital technology, people who have limited access to equipment and the internet, people who are experiencing homelessness, and people living in homes of multiple occupancy or in residential care. Additional support may be needed for people who have visual, hearing or cognitive impairment, reduced manual dexterity or a learning disability, people who do not have English as a first language or understand health-related information. People's cultural, ethnic or religious backgrounds may affect how cardiac rehabilitation should be delivered. These people should be supported through shared decision making to select the appropriate treatment option for them and may need additional support.

More research is needed

There is not enough evidence to support funding in the NHS for the 7 technologies listed in recommendation 1.4.

Access to technologies should be through company, research or non-core NHS funding, and clinical or financial risks should be managed appropriately.

What evidence generation and research is needed

Evidence generation and research is needed on:

the clinical effectiveness of digital technologies to support cardiac rehabilitation compared with conventional cardiac rehabilitation
the clinical effectiveness of offering both digital and conventional cardiac rehabilitation compared with conventional cardiac rehabilitation alone
how changing from paper to digital manuals affects clinical effectiveness
the comparative costs of delivering digital and conventional cardiac rehabilitation, including implementation and training.

The evidence generation plan gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources. It includes how the evidence gaps could be resolved through real-world evidence studies.

Why the committee made these recommendations

Digital technologies to support cardiac rehabilitation are a possible option for people with CVD to self-manage their care at a time and location that is convenient to them. A potential benefit is that these technologies could improve access, uptake and adherence to cardiac rehabilitation programmes. This could reduce unplanned hospital admissions and acute cardiovascular events resulting from the condition deteriorating.

Activate Your Heart, D REACH-HF, Digital Heart Manual, Gro Health HeartBuddy, KiActiv and myHeart have clinical evidence that supports their use in the UK. UK-based clinical evidence for Activate Your Heart, Gro Health HeartBuddy, KiActiv and myHeart suggests that they may reduce the risk of secondary cardiovascular events. The clinical evidence for D REACH-HF and Digital Heart Manual is uncertain. There is evidence of clinical benefit for the paper manuals widely used in the NHS that these technologies are based on, but no evidence that the digital technologies offer the same benefit. But, these uncertainties can be addressed through evidence generation.

Early economic evidence for these 6 technologies suggests that they could be cost effective.

Clinical evidence on Datos Health and R Plus Health was not generalisable to cardiac rehabilitation programmes in the UK. There was no evidence for Beat Better, Get Ready – Solution, Luscii vitals, Pumping Marvellous Cardiac Rehab Platform or Sword Move. So, these 7 technologies can only be used in research to generate more clinical and economic data.

How are you taking part in this consultation?

HealthTech draft guidance