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Spotlight tools to improve routine clinical care

Multi-centre randomised controlled trial to determine the clinical and cost-effectiveness of Spotlight-AQ

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15511689
Enrollment
200
Registered
2021-10-11
Start date
2021-10-01
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes, type 2 diabetes, pre-diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus, Type 2 diabetes mellitus

Interventions

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
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 thi

Sponsors

Southern Health NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Aged <18 years 2. Mental illness that could seriously reduce their ability to participate in the study 3. Lack of capacity

Design outcomes

Primary

MeasureTime frame
Consultation duration time measured by timing each consultation at baseline, 3, 6, 9 and 12 months follow-up

Secondary

MeasureTime frame
Measured at baseline, 3, 6, 9 and 12 months follow-up: 1. Diabetes distress measured using the Diabetes Distress Scale (DDS) 2. Depression measured using Patient Health Questionnaire (PHQ)-9 3. Anxiety measured using Generalised Anxiety Disorder (GAD)-7 4. Social functioning measured using 12-Item Short Form Survey (SF-12) 5. Engagement measured using the Self-Care Inventory (SCI) 6. Treatment satisfaction/utility measured using the Diabetes Treatment Satisfaction Questionnaire 7. Health resource utility measured using EQ-5D (EuroQol five dimension) 8. Well-being measured using World Health Organisation- Five Well-Being Index (WHO-5) 9. HCP burnout measured using the Maslach Burnout Inventory

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026