Well-Track: Wearable activity/sleep tracker for health & wellbeing
| ISRCTN | ISRCTN22197467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22197467 |
| IRAS number | 295193 |
| Secondary identifying numbers | V1, IRAS 295193 |
- Submission date
- 11/02/2021
- Registration date
- 19/04/2021
- Last edited
- 04/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Poor sleep hygiene and low levels of physical activity are linked to poor mental and physical health in people experiencing psychosis. People with experience of psychosis are more likely to have low levels of physical activity and high levels of sedation and sleep disorders are common (80% of people with psychosis). Low levels of psychical activity and poor sleep in psychosis are thought to be connected.
Regular physical activity has a beneficial impact on well-being and is an effective preventative strategy against many chronic medical conditions. For people with psychosis, engaging in physical exercise is associated with improved symptoms of psychosis, quality of life, functioning, and physical health. In patients with mental health disorders sleep problems should be assessed, monitored, and treated, and sleep hygiene advice for sleep problems in psychosis may be beneficial.
Studies have shown that people with serious mental illness find wearing a Fitbit activity/sleep tracker to be acceptable, motivating, and useful for enabling goal setting and healthier lifestyles. Using a Fitbit tracker and providing sleep hygiene advice and training and physical exercise advice and opportunities could improve wellbeing and physical health in people with psychosis.
This study aims to investigate the impact of using a Fitbit tracker and providing sleep and physical exercise advice on sleep, physical activity, wellbeing, and health in people with psychosis. The study will also explore how best to integrate similar advice and use of technology in mental health services.
Who can participate?
Early psychosis service patients aged 18 to 65 years
What does the study involve?
Participants who are in an early psychosis service will be offered the use of a Fitbit, sleep hygiene advice/training, and physical exercise advice/opportunities for an 8 week period with the aim of enhancing wellbeing and physical health. All participants receive the same programme. If participants are identified as having sleep problems they will also be offered the ‘Sleepio’ on-line sleep hygiene training programme, which has demonstrated significant reductions in insomnia, paranoia, and hallucinations.
In-depth interviews will be used to explore participant experiences of the programme, factors influencing physical activity and sleep, and to gain an understanding of how participants can best use technology, sleep hygiene and physical exercise advice.
What are the possible benefits and risks of participating?
Participants may find the Fitbit, sleep and exercise advice, and engagement useful, as it may improve sleep, mental health, and physical health. Participants may benefit from having the opportunity to describe their experiences and so be able to make sense of and process these with a receptive listener. They may find it therapeutic or useful to enable reflection or feel affirmed from recalling what has been good about their experiences. They may feel a sense of contribution as their feedback and ideas may improve care and treatment for others.
Having a Fitbit, completing brief assessments, providing feedback, and being interviewed is not considered to have a high risk of harm. Participants may find discussing issues related to mental and physical health, physical exercise, and sleep uncomfortable or distressing.
Where is the study run from?
Northamptonshire Healthcare NHS Foundation Trust
When is the study starting and how long is it expected to run for?
From January 2021 to December 2021
Who is funding the study?
The project is funded by UK Research and Innovation (UKRI) through the University of York ‘Closing the Gap’ Network (UK)
Who is the main contact?
Dr. Chris Griffiths, chris.griffiths@nhft.nhs.uk
Contact information
Scientific
Berrywood Hospital
Berrywood Drive
Northampton
NN5 6GQ
United Kingdom
 ORCID ID |
0000-0002-6377-907X |
|---|---|
| Phone | +44 (0)1604685528 |
| chris.griffiths@nhft.nhs.uk |
Study information
| Study design | Single-site mixed-method design non-randomized study with no control, employing pre and post measures |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The Well-Track project: mental health service integration of wearable activity and sleep trackers for improving health and wellbeing in early psychosis |
| Study acronym | Well-Track |
| Study hypothesis | The study will ask: 1. What is the impact of the intervention on sleep, physical activity, weight, wellbeing, and mental health? 2. What are the links between patient factors, measures of sleep, physical activity, weight, wellbeing, and mental health? 3. What are the experiences and feedback of patients? The aims of the study are that: 1. Participants will be empowered to have improved control over their sleep, physical activity, health, and wellbeing 2. Participants will have better sleep, physical fitness, health, and wellbeing 3. The study team will gain an understanding of how people with experience of psychosis can best use technology, sleep hygiene, and physical exercise advice/opportunities 4. The study team will gain an insight into how participants involve friends, carers, family, and professionals in staying fit and healthy 5. The study team will gain an understanding of how project intervention can be integrated into services and benefits can be maximised |
| Ethics approval(s) | Approved 11/03/2021, Leicester South REC (Health Research Authority, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8115; helen.poole@hra.nhs.uk), REC ref: 21/EM/0047 |
| Condition | First or early psychosis |
| Intervention | The study involves an 8 week intervention using a Fitbit, sleep hygiene advice/training and physical exercise advice/opportunities for patients in an early psychosis service. If people are identified as having sleep problems they will be offered the ‘Sleepio’ on-line sleep hygiene training programme, which has demonstrated significant reductions in insomnia, paranoia and hallucinations. |
| Intervention type | Mixed |
| Primary outcome measure | BMI calculated from weight and height measured at baseline and 8 weeks |
| Secondary outcome measures | 1. Physical activity measured using steps and intensive activity collected by the Fitbit between baseline and 8 weeks 2. Sleep measured using the duration of sleep and wake after sleep onset (WASO) collected by the Fitbit between baseline and 8 weeks 3. Well-being measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) collected at baseline and 8 weeks 4. Positive and negative affect measured using the Positive and Negative Affect Schedule (PANAS) collected at baseline and 8 weeks |
| Overall study start date | 01/01/2021 |
| Overall study end date | 06/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 41 |
| Participant inclusion criteria | 1. Aged 18 to 65 years 2. Patient of early psychosis service 3. Understands written and oral English 4. Based in the community |
| Participant exclusion criteria | 1. Unable to wear a watch-like device on their wrist 2. Do not have capacity to consent |
| Recruitment start date | 01/03/2021 |
| Recruitment end date | 01/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Kettering
NN15 7PW
United Kingdom
Sponsor information
Hospital/treatment centre
Berrywood Hospital
Berrywood Drive
Duston
Northampton
NN5 6UD
England
United Kingdom
| Phone | +44 (0)1604682623 |
|---|---|
| Itai.Matumbike@nhft.nhs.uk | |
| Website | https://www.nhft.nhs.uk/ |
"ROR" |
https://ror.org/0358tcd02 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Findings will be disseminated through peer-review journals, media sources and conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/02/2022 | 08/02/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/04/2022 | 04/09/2023 | Yes | No | |
| Results article | 26/04/2022 | 04/09/2023 | Yes | No |
Editorial Notes
04/09/2023: Publication references added.
08/02/2022: Publication reference added.
08/12/2021: The following changes were made to the trial record:
1. Ethics approval details added.
2. The recruitment end date was changed from 01/12/2021 to 01/11/2021.
3. The overall trial end date was changed from 31/12/2021 to 06/12/2021.
4. Total final enrolment added.
15/02/2021: Trial’s existence confirmed by University of York ‘Closing the Gap’ Network.
