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| ID | Type | Description | Link |
|---|---|---|---|
| PGfAR NIHR205441 | Other Grant/Funding Number | National Institute of Health Research (NIHR) |
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Up to one in two adults with type 1 diabetes find living with and managing diabetes to be emotionally challenging. This 'emotional side' of diabetes - feeling worried, frustrated, overwhelmed, sad, burnt-out - is called diabetes distress. It affects people's quality of life and can hinder them from managing their diabetes as well as they can.
In the UK, the NHS needs to better understand how to best support people feeling emotionally burdened by diabetes. So, we have worked with diabetes distress specialists around the world to develop an NHS pathway to care for diabetes distress. This pathway to care involves training diabetes teams to recognise, assess and talk about diabetes distress at routine appointments. If people have a high diabetes distress level, they may be able to take part in an online group program to help them manage their type 1 diabetes and emotions. The feasibility study will test this pathway to care with people with type 1 diabetes in the NHS setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care (EUC) | Active Comparator | This arm of the study involves health care professionals e-learning training in and delivery of EUC for the detection and management of diabetes distress. |
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| REDUCE Programme Intervention | Experimental | REDUCE intervention is an online group 6 session programme for the management of elevated diabetes distress. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-stress study: The detection, prevention and management of diabetes distress for adults living with type 1 diabetes. | Behavioral | Enhanced Usual Care intervention aims to train health care professionals to detect and prevent, and manage diabetes distress in routine diabetes care, in the UK NHS. The REDUCE programme aims to prevent and manage elevated diabetes distress. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, service use, acceptability, attrition rate and data quality | The main primary outcome measure is to assess the feasibility of the study in relation to progressing to the proposed main trial. As part of the primary outcome the study investigators will be assessing the following:
| The study investigators will be collecting data to assess the primary outcome measure at Month 3 and Month 6 of the study. |
| Diversity of recruited participants against nine protected characteristics | The study investigators will be assessing the diversity of recruited participants against against nine protected characteristics with the D-stress study specific measurement tool called, the Health and social equalities. | This primary outcome data will be collected at month 3 baseline data collection and month 6 follow-up data collection. |
| To assess the quality of data collected | As part of the primary outcome the study investigators will be assessing the quality of data collected via monthly questionnaires using the Acceptability, feasibility and appropriateness of implementation (AIM) (Sturt, Griffiths et al. 2023; Weiner, Lewis 2017), measurement tool realist evaluation process interviews and non-participant observation with study investigators following RAMESES quality and publication standards guidelines (Wong G, Greenhalgh T, Westhorp G, et al. 2013). | The study investigators will be collecting data to assess the primary outcome measure at monthly throughout the duration of the 6 month study. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of initial Realist Process Evaluation programme theories | Assessing whether the initial programme theories underpinning Enhanced Usual Care (control) and REDUCE programme (experimental) explain the outcomes and participant experiences of these interventions. Non-participant observations of control and experimental intervention will be conducted. Realist Process Evaluation interviews with study participants will also be conducted over the course of the study: from day 1 (month 1) through to month 6. |
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Inclusion Criteria:
Adults with type 1 diabetes
Health care professionals
Family or friend
REDUCE Facilitators
• Eligibility as per the role specification in Section 6.2.2 of study Protocol
Exclusion Criteria:
Adults with type 1 diabetes
Health care professionals • People who are unwilling or unable to take on additional workload associated with D-stress e-learning and delivery of Enhanced Usual Care.
Family or friend
• Participant with type 1 diabetes has not given consent for a family member or friend to participate in the study
REDUCE Facilitators
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal United Hospitals Bath | Recruiting | Bath | United Kingdom |
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| Conducted over the course of the feasibility study from Day 1 through to the completion of the study, an average of 6 months. |
| Proportion of TIR for interstitial blood glucose (proposed main trial co-primary outcome) | The proportion of time interstitial blood glucose is in the range of 4-10 mmol/l (Battelino, Alexander et al. 2022). This will be collected via the participant's continuous glucose monitoring (CGM) device every 30 days (each month) from the start of the study (month 1) through to study completion, an average of 6 months. In addition to proportion of time interstitial blood glucose is in the range , below range, above range, and glucose variability, measured as coefficient of variation will be measured. Percentage of CGM sensor usage will also be measured. This will allow study investigators to determine the completeness of interstitial blood glucose sensor data and proportion of time in the preceding month the participant's blood glucose was in range. | CGM data will be collected monthly from Month 1 through to study completion, an average of 6 months. |
| Diabetes distress score (proposed main trial co-primary outcome) | The Type 1 Diabetes Distress Assessment Scale T1-DDAS 8-item CORE scale will be the key scale used to collect diabetes distress levels. Items are scored between 1 and 5, with one being Not a problem to five being A very serious problem. A core score of under 3 on each item is sub-threshold and ≥3 is elevated. The tool was 'developed and validated and standardized' for adults with Type 1 diabetes by the Behavioural Diabetes Institute to further specify the source of DD as well as the amount of DD (Institute, 2023; Fisher, Polonsky et al. 2024). | The T1-DDAS measurement scale will be used every 30 days from Month 1 through to study completion, estimated to be 6 months. |
| University Hospitals Leicester NHS Trust | Recruiting | Leicester | LE1 7RH, | United Kingdom |
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| Guy's and St Thomas' Hospitals NHS Trust | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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