Spotlight tools to improve routine clinical care
| ISRCTN | ISRCTN15511689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15511689 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 289964 |
| Protocol serial number | IRAS 289964, CPMS 47856 |
| Sponsor | Southern Health NHS Foundation Trust |
| Funder | Investigator initiated and funded |
- Submission date
- 08/10/2021
- Registration date
- 11/10/2021
- Last edited
- 31/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Routine patient care visits currently leave both patients and healthcare professionals feeling frustrated both in primary and specialist care settings. The lack of understanding of the psychological and social burden of diabetes and the evolving consequences results in a negative impact on clinical practice with negative outcomes for patients and increasing frustration for healthcare professionals. The aim of this study is to determine the clinical and cost-effectiveness of the Spotlight Consultations tools in routine primary or secondary care clinic appointments between healthcare professionals and adults with type 1 diabetes, type 2 diabetes or pre-diabetes.
Who can participate?
Patients aged 18 and over with type 1 diabetes, type 2 diabetes or pre-diabetes treated in primary or secondary care
What does the study involve?
The researchers are testing the usefulness of a new digital health tool called: ‘Spotlight’ in helping healthcare professionals better understand their patients’ priority concerns during routine diabetes clinic visits. Despite the therapies available, people with type 1 diabetes, type 2 diabetes and pre-diabetes often are unable to reach blood glucose targets for optimal health. Improving routine consultations could help.
Participants will be randomly assigned to the intervention group or the control group. Those in the intervention group will be asked to complete study questionnaires and the Spotlight Consultations online pre-clinic assessment before their routine outpatient consultation. Results of this assessment will form the basis of discussion during the consultation. Those in the control group will be asked to complete stud questionnaires only. At the end of the intervention period, all participants in the control group will be offered the use of the Spotlight Consultations pre-clinic assessment.
What are the possible benefits and risks of participating?
Participants may learn more about the factors in their everyday life that impact their diabetes and the way they manage it. Participants may learn more about how diabetes affects their life and contribute to research that may benefit others.
The risks associated with taking part are very small. Taking part may make participants think more about their own mood, how they feel about their diabetes, and the impact of their diabetes management on their quality of life.
Where is the study run from?
Southern Health NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2020 to December 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Prof. Katharine Barnard-Kelly, katharinebarnard@bhrltd.com
2. Dr Peter Phiri
Contact information
Scientific
Southern Health NHS Foundation Trust
Tom Rudd Unit
Southampton
SO303BJ
United Kingdom
 ORCID ID |
0000-0002-3888-3123 |
|---|---|
| Phone | +44 (0)7590532866 |
| katharinebarnard@bhrltd.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 40529_PIS_HCP_V1.6_08Oct21.doc |
| Scientific title | Multi-centre randomised controlled trial to determine the clinical and cost-effectiveness of Spotlight-AQ |
| Study acronym | Spotlight-AQ |
| Study objectives | The hypothesis is that it is feasible and acceptable using the Spotlight Consultations tool, to improve outpatient visits, ensuring patient-driven healthcare to match the most relevant and appropriate care pathways to the personalized needs of the individual, thus optimizing outcomes and reducing the burden on both the person with diabetes and the healthcare professionals. |
| Ethics approval(s) | Approved 03/02/2021, Wales REC7 (Health and Care Research Wales, Health and Care Research Wales Support Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 230457, +44 (0)7920 565664; Wales.REC7@wales.nhs.uk), REC ref: 21/WA/0020 |
| Health condition(s) or problem(s) studied | Type 1 diabetes, type 2 diabetes, pre-diabetes |
| Intervention | Following recruitment and consent, each participant will complete baseline questionnaires. Participants will then be randomized into either the intervention arm or the control arm of the study at each centre for a period of 12 months (i.e. baseline and follow-up visits). The researchers will randomise on a 1:1 basis using computerised randomisation software. Those in the intervention group will be asked to complete study questionnaires and the Spotlight Consultations online pre-clinic assessment prior to their routine outpatient consultation. Results of this assessment will form the basis of discussion during the consultation. Those in the control group will be asked to complete study questionnaires only. At the end of the intervention period, all participants in the control group will be offered the use of the Spotlight Consultations pre-clinic assessment. Clinic visits will occur every 6 months i.e. baseline, 6 and 12 months within the intervention period. Haemoglobin A1c will be assessed, together with psychosocial outcomes throughout the trial, i.e. reflecting routine clinical care. The 12-month duration of the intervention is determined by the goal to observe meaningful A1c changes AND reduced consultations times, alongside improvements on PROs; reduced burden/distress of HCPs and is sufficient for this purpose. The researchers have considered alternative designs, such as a cluster randomised controlled trial, however, it was decided that this approach would be more appropriate in order to minimize the number of participants needed for recruitment, and optimizes the total time and effort. Following the study, the participating centres may keep the tools and offer them to those in the control group. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Consultation duration time measured by timing each consultation at baseline, 3, 6, 9 and 12 months follow-up |
| Key secondary outcome measure(s) |
Measured at baseline, 3, 6, 9 and 12 months follow-up: |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 98 |
| Key inclusion criteria | 1. Aged ≥18 years. There is no upper age limit 2. Diagnosed with type 1 diabetes or at risk of or diagnosed with type 2 diabetes (including pre-diabetes) for at least 6 months 3. Any diabetes treatment 4. Willing/able to use the Spotlight Consultations tool 5. Ability to give informed consent 6. Ability to speak and read English fluently |
| Key exclusion criteria | 1. Aged <18 years 2. Mental illness that could seriously reduce their ability to participate in the study 3. Lack of capacity |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Tom Rudd Unit
Botley Road
Southampton
SO30 3BJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to commercial sensitivity. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/06/2023 | 29/08/2023 | Yes | No | |
| Results article | 30/01/2025 | 31/01/2025 | Yes | No | |
| Protocol article | 20/06/2022 | 21/06/2022 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | HCP version 1.6 |
08/10/2021 | 11/10/2021 | No | Yes |
| Participant information sheet | Participant version 1.9 |
08/10/2021 | 11/10/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.10 | 03/02/2021 | 11/10/2021 | No | No |
Additional files
- 40529_PIS_HCP_V1.6_08Oct21.doc
- HCP
- 40529_PIS_Participant_V1.9_08Oct21.doc
- Participant
- 40529_PROTOCOL_V1.10_03Feb21.pdf
- Protocol file
Editorial Notes
31/01/2025: Publication reference added.
29/08/2023: Publication reference added.
21/06/2022: Publication reference added.
14/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2022 to 30/09/2022.
2. The overall trial end date was changed from 31/12/2022 to 30/09/2023.
3. The intention to publish date was changed from 01/08/2022 to 01/08/2023.
01/11/2021: The CPMS number was added.
11/10/2021: Trial's existence confirmed by Wales REC7 (Health and Care Research Wales).
