Terve Päivä – digital lifestyle guidance

Terve Päivä is a digital lifestyle guidance treatment pathway and service platform developed in collaboration with healthcare professionals. It provides professionals with a means to guide clients both in a preventive manner and as in support of pharmacotherapy. For clients, the service provides a structured pathway towards a healthier lifestyle, including a better diet, increased exercise, and stress management. The service works through a browser-based user interface and is available on a variety of devices, including computers, tablets, and smartphones. [1]  

The objective of the Terve Päivä service is to promote health and well-being through various lifestyle changes. The service offers three complete six-month pathways, the contents of which are based on current care recommendations:     

• General lifestyle guidance 

• Diabetes 

• Obesity 

According to information received from the company, 90% of the users of the service will continue until the end of the six-month service period. [1] 

Research evidence relating to the product under evaluation 

The product has undergone a peer review study to evaluate the effectiveness of the Terve Päivä service’s six-month digital health intervention in early-stage diabetics as well as type 2 diabetics. The digital service pathway used in the assessment aims to support a comprehensive change in the client’s lifestyle. The service pathway included diverse lifestyle topics such as eating habits, physical activity, as well as monitoring of the client’s progress and support from a nurse or a doctor. [2] 

The data from the study was collected using an online questionnaire. Data were collected on the weight, height, and waist circumference of the participants before and after intervention. Anthropometric data were collected from 23 subjects with prediabetes and 33 subjects with type 2 diabetes. More than half of the respondents were men with type 2 diabetes with an average age of 60 years. The participants averaged a body weight of 92 kg, a body mass index (BMI) of 32 kg/m2 and a waist circumference of 109 cm. [2] 

In addition to the anthropometric data, the study also collected health data, such as data on physical activity, eating habits, and experience of the state of health. 52 people provided health data for the study. The majority of respondents were women, 26 with prediabetes and 26 with type 2 diabetes.  Their average age was 61 years. [2] 

Pre- and post-operative changes during the intervention period as well as differences in responses between prediabetic patients and type 2 diabetics were evaluated using non-parametric analyses.  

During the intervention period, participants lost an average of 3.0 kg of weight (-6.0 – -1.0 kg p < 0.001), their BMI decreased by 0.90 kg/m in2 (-2.02 – 0.10, p < 0.001), and waist circumference decreased by 4.0 cm (p < 0.001). Their observed state of health (p < 0.001), dietary habits (p < 0.001), and physical activity habits (p < 0.001) were estimated to have improved accordingly. Changes during the intervention period did not differ between prediabetics and type 2 diabetics. [2] 

The study concluded that the beneficial effects of the 6-month digital intervention on health-related behavioural changes in prediabetics and type 2 diabetics could be demonstrated. Regular professional guidance combined with the digital pathway will improve the effectiveness of the intervention.  

There were no randomly selected participants or control groups in the study. However, the sample, based on registry data, is representative of those groups of diabetics who were advised to participate in the intervention as part of the normal course of clinical treatment. [2] 

Literature reviews 

A systematic literature review, completed in 2020, investigated the clinical impacts of digital tools in health coaching, education, and behavioural promotion in patients with prediabetes or type 2 diabetes. The purpose of the systematic review was to provide input to support decision-making for those health care organisations considering adopting such digital tools. [3] 

In the systematic review, 20 of the 21 studies included in the review demonstrated statistically significant improvements in at least one measure of diabetes management, such as long-term glucose (hbA1c), fasting blood sugar (fP-Glucose), and body mass Index (BMI). Weight loss at one year ranged from -3.04% to -8.98%, which corresponds to results achieved through traditional coaching in the course of preventive diabetes treatment. Four studies reported weight loss within these percentages. In addition, studies comparing online coaching with personal or telephone coaching showed statistically superior or equivalent results for the online training group. There were five such studies (N = 5). [3]  

The conclusion of this review was that digital health coaching provides a promising strategy for the long-term management and prevention of type 2 diabetes, and its benefits are comparable to in-person or telephone coaching. [3] 

A study completed in 2019 assessed the effects of a digital intervention tool on diabetic patients in eight municipalities in Denmark between 2016 and 2018. Each of the eight municipalities offered a digital intervention platform through its own organisation with the help of local health care professionals such as nutritional therapists, nurses, physiotherapists, and occupational therapists. In the study, changes in body weight were assessed at 6, 9 and 12 months. [4] 

The population consisted of 103 diabetic patients, 57 of whom were women (55.3%). All participants’ BMI at baseline was > 30 kg/m2. Patient data was collected from the intervention database based on data registered by patients and their respective professionals and the data met the following criteria:  

• The subjects had registered as users of the platform due to diabetes.  

• The digital intervention platform was in use at some point during the time period the material was collected (7 June 2016 through 2 May 2018). 

• There were at least 90 days and no more than 365 days between registration of the first and last weight measurement. 

• No unrealistically fast weight changes were recorded during the data collection (> 0.5 kg/day). 

The majority of patients in the study, 88/103 (85.4%) lost weight, while 15/103 (14.6%) maintained or increased their weight. The results demonstrated an average weight loss of 4.8 kg (4.3%) from the original body weight over a period of approximately 7 months (P < .05). Female patients lost 4.22% of their original body mass, while men lost 4.41% of their weight. 

The study also found that the time spent on the intervention was a significant factor in weight loss. The change in body weight in patients who had recorded their body weight for 9 months was a weight loss of (5.56%) and the mean weight loss in patients who had recorded their body weight for 12 months was (6.27%). [4] 

Recommendations and previous assessments 

The National Institute for Health and Care Excellence (NICE) has issued its recommendations on the use of digital weight management technologies in the UK health care sector. These recommendations focus on assessing the clinical effectiveness of weight management technologies.  

Digital weight management technologies are an integral part of the recommendations, offering an alternative to traditional face-to-face weight management services. Preliminary evidence suggests that the weight loss achieved through the technologies is comparable to traditional services over a two-year period. [5] 

The recommendations also noted that diverse weight management programmes incorporating dietary habits, physical activity, and behavioural change techniques can help adults lose weight and maintain weight management for at least 12-18 months. This provides some evidence of how diverse technologies can effectively complement the health care weight management strategy. [6] 

The company is not aware of any adverse events pertaining to clients that might have resulted from use of the service. According to the company, the Terve Päivä service poses no significant risks to the client, because the client is guided to lifestyle changes based on medical recommendations and with the support of a personal carer. The primary responsibility for client safety lies with the client’s Terve Päivä personal nurse, who is a health care professional. The client is always advised to follow the instructions given by their doctor. [1] 

The company has prepared a risk analysis and a risk management plan that also assesses possible risks from the client’s perspective. According to the company, it is committed to continuously improving its services and updating its risk analysis and risk management plan. The company has plans to report any adverse events to Fimea even though it is not a medical device. The company has designated a person responsible for handling incident reports. [1] 

If necessary, an external patient ombudsman service is also available through the company [1].  

The service needs an Internet connection to function correctly. [1] 

The costs are determined on the basis of the service content ordered and the number of clients. The service is also available for self-paying customers [1]. 

Pricing on the basis of the number of clients may be conducted either as: 

• a quantity-specific order, in which the service is provided for a certain number of clients to be set on a case-by-case basis;  

• or, an unlimited licence based on the size or population base of the unit, municipality, or wellbeing services county using the service.  

There are no setup costs for implementing the product if the service is deployed without integrations. The use of the service does not require integration [1]. 

The costs of using the service are reasonable compared to providing a similar service in other ways.
 

The assessment was carried out using the list of data security and protection requirements for social welfare and health care procurement and the response material provided by SaraWell Oy [1]. 

Risk management and data security testing 

The Terve Päivä application and system are subject to regular security testing to allow further development. The risk management plan encompasses the data security risks of the company and its services as well as risk-specific management measures. The company does not have a plan for regular manual penetration testing. The employees of SaraWell Oy complete a short online course going over basic data security issues. 

Log management 

The company collects comprehensive log data, particularly in the technical domain, with specified processes and persons for handling the data. Operations associated with backing up client data are not logged. Access to system log data is not controlled. OneByte Oy, the service software provider, retains the ability to monitor and manage log data.  

User management 

The service supports role-based access management. After receiving the usernames, the client logs into the service with their banking ID or a mobile certificate. In the future, multi-step identification can be introduced. User data is not shared with external services. 

Hardware 

Terve Päivä is a browser-based service that the client can use on a mobile device or computer. OneByte Oy is responsible for the server infrastructure. The implementation is based on the cloud services provided by CloudFlare and Amazon.  

Data protection 

The data is stored in Finland and will not at any point be transferred outside the EU/EEA. All passwords are encrypted according to current standards with sufficiently strong algorithms. A data protection impact assessment (DPIA) has been conducted for the Terve Päivä application. User data will be deleted or anonymised three weeks after the termination of the user’s access rights.  

General guidance on procurement  

During the purchase phase it is always important to contact the IT management, data security specialist and data protection specialist of the organisation. Please discuss with them whether the product in question fulfils your requirements. In addition, we recommend that the wellbeing services counties utilise the European Union Agency for Cybersecurity’s (ENISA) data security procurement guidelines as support in the procurements [9]. 

The Terve Päivä service provides the same user interface for both health care professionals and clients. The user interface scales with the device used (computer, tablet, smartphone). The service can be used either under the guidance of a health care professional or independently as a self-paying client.  

According to the company, the use of the service does not have exclusion criteria, because the service guides and advises users to find ways and means specific to themselves to change their lifestyles. A health care professional will always assess on a client-by-client basis who would benefit from the service. The professional may be either a nurse with SaraWell Oy or one employed by the purchaser organisation. The Terve Päivä service has had over a thousand clients so far and their age distribution has been between 18 and 85 years. [1] 

Usability 

According to the company, the service has proven to be easy to use in user testing, even for customers with limited it expertise. Occasionally, there have been problems with the strong authentication required to log into the service, or with the language settings in the client’s browser. These difficulties have usually been caused by the client’s browser settings, which have prevented the redirection to strong identification, or the web browser’s automatic language translation has interfered with the text of the Terve Päivä service by interpreting it as a language other than Finnish. The user manual provides instructions on how to handle problems with browser settings. [1] 

According to the company, the user interface is designed to be intuitive, that is to say, it directs the customer to proceed in the service in a simple and easy-to-understand manner. In 2021, when the service was introduced, usability testing was carried out with test users. Based on the results, the content and functionality have been further developed. The user interface was revamped in 2022, which further improved the user experience. The company constantly collects client feedback from users, monitors the regulation of digital services and modifies its content whenever necessary. [1] 

Accessibility 

The service meets the WCAG 2.1 A and AA level requirements. Its accessibility has been audited by an external expert organisation. The accessibility statement is available in the application and is also available on the tervepaiva.fi website [7]. A client may report accessibility problems to the company through the electronic feedback channel and the company promises to respond within 14 days. The Themes and Sections of the service are produced using the Articulate 360 software.  

The service pays attention to special user groups in the following ways: 

• the contrast between the text or illustration and the background is sufficient 

• browser pages can be magnified 

• the content can also be listened to 

• the content supports screen reader programs, e.g. a screen reader recognizes titles and images have text equivalents   

• the service includes text and image material, gamified functions, and subtitled videos 

• no bright or flashing lights or videos have been used in the service. 

General guidance on procurement  

The purchasing organisation shall take into account the accessibility requirements set out in the legislation in force at the time [10-12]. 

Interoperability 

The service can be integrated into the electronic patient records or another user interface of the purchaser. At the time of the assessment, no such integrations have yet been implemented in practice. [1] 

It is possible to use the service in conjunction with other health and well-being devices [1]. 

The data collected by the service can be made available if necessary, in e.g. an Excel file format [1]. 

Technical functionality 

The company monitors the system and its operation to identify faults [1]. Customers will be informed by mass message through the encrypted messaging system of the service in case of an anticipated downtime of more than five minutes [1].  

If necessary, it is possible to revert to an earlier version of the application [1]. 

In the last six months, the service has never been out of use [1]. 

Training and product support 

A short deployment training will be provided to professionals before the Terve Päivä service is introduced. The duration of the training is one hour and it will be held in Finnish. The client is provided with an instructional video and user instructions provided by a professional within the purchaser organization when establishing a client relationship. [1]  

The Terve Päivä personal nurse provides product support to the client. They can either an employee of either the purchaser organisation or SaraWell Oy. The company provides product support to the purchasing organisation or, if necessary, the company can be contacted using the contact form at tervepaiva.fi. [1] 

Product distribution 

The service has been in use in Iitti, the basic social and health care services of Pori, as well as the joint municipal authorities of Kallio and Oulunkaari.  

At the time of the assessment, the service is available in Karvia, Alavieska, Hattula, Täsmä Työterveys Oy, and the Riihimäki pharmacy. [1] 

1. The Digi-HTA questionnaire filled out by the company, not public information.
2. A 6- Month Digital Intervention to Promote Health-related Lifestyle Change in Pre-Diabetics and Type 2 Diabetics – a quasi – experimental study. Manuscript. Submitted for review.
3. Gershkowitz BD, Hillert CJ, Crotty BH. Digital Coaching Strategies to Facilitate Behavioral Change in Type 2 Diabetes: A Systematic Review. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1513-e1520. doi: 10.1210/clinem/dgaa850. PMID: 33206975. Accessed on 11.6.2024. 
4. Komkova A, Brandt CJ, Hansen Pedersen D, Emneus M, Sortsø C. Electronic Health Lifestyle Coaching Among Diabetes Patients in a Real-Life Municipality Setting: Observational Study. JMIR Diabetes. 2019 Mar 12;4(1):e12140. doi: 10.2196/12140. PMID: 30860486; PMCID: PMC6434397. Accessed on 11.6.2024. 
5. National Institute for Health and Care Excellence. 2023. Digital technologies for delivering specialist weight-management services to manage weight-management medicine: early value assessment. https://www.nice.org.uk/guidance/hte14/resources/digital-technologies-for-delivering-specialist-weightmanagement-services-to-manage-weightmanagement-medicine-early-value-assessment-pdf-50261971277509. Accessed on 28.6.2024 
6. National Institute for Health and Care Excellence. 2014. Weight management: lifestyle services for overweight or obese adults. https://www.nice.org.uk/guidance/ph53/resources/weight-management-lifestyle-services-for-overweight-or-obese-adults-pdf-1996416726469. Accessed on 28.6.2024 
7. Terve Päivä saavutettavuusseloste (Accessibility statement) available at https://tervepaiva.fi/saavutettavuusseloste/. Accessed on 18.6.2024
8. National Cyber Security Centre: Information security and data protection requirements for social welfare and healthcare procurements. Available at: https://www.kyberturvallisuuskeskus.fi/en/ncsc-news/instructions-and-guides/information-security-and-data-protection-requirements-social. Accessed on 18.6.2024
9. The European Union Agency for Cybersecurity Procurement Guidelines for Cybersecurity in Hospitals. Saatavilla: https://www.enisa.europa.eu/publications/good-practices-for-the-security-of-healthcare-services. Accessed on 18.06.2024 
10. Act on the Provision of Digital Services 306/2019 (Available only in Finnish). Available at: https://www.finlex.fi/fi/laki/alkup/2019/20190306 Accessed on 18.6.2024
11. Regional State Administrative Agency of Southern Finland, Accessibility supervision unit. The requirements of the Act on Provision of Digital Services. Available at: https://www.webaccessibility.fi/requirements-of-the-act-on-the-provision-of-digital-services/  Accessed on 18.6.2024
12. Act on public Procurement and concession contracts 1397/2016 (Available only in Finnish). Available at: https://www.finlex.fi/fi/laki/alkup/2016/20161397  Accessed on 18.6.2024

Jari Haverinen, erikoissuunnittelija, FinCCHTA 

Raija Järvinen, erikoissuunnittelija, FinCCHTA 

Teemu Mustola, erikoissuunnittelija, FinCCHTA 

Tommi Hanhela, tietoturva-asiantuntija, Oulun yliopisto 

Jere Kinnunen, tietoturva-asiantuntija, Oulun yliopisto 

Antti Koskela, tietoturva-asiantuntija, Oulun yliopisto