Diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: For healthcare professionals (HCPs), the inclusion criteria are: 1. Male or female 2. 18 years or over 3. GPs involved in the care of people with diabetes within Greater Manchester 4. Able to provide informed consent Patient data from four GP practices will be utilised - data will be from patients who are: 1. Male or female 2. Aged 18 years or over 3. Diagnosis of diabetes (any type)
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. System safety: frequency of user-flagged safety concerns measured using a combination of patient-level questionnaires, weekly questionnaires and unsolicited issues highlighted by participants. Specific measures include: 1.1. Number of risks identified by patient-level questionnaires (interim and cumulative total), expressed as a percentage of the number of patient records reviewed 1.2. Clinical safety score recorded with a weekly questionnaire for each of the MWIQ features (diabetes sub-type predictor, diabetes drug response predictor, and diabetes complications predictor) as well as overall experience. The score will be recorded on a 5-point Likert scale and the distribution of scores will be expressed as a percentage of responses received. 1.3. Clinical plausibility score recorded with a weekly questionnaire for each of the MWIQ features (diabetes sub-type predictor, diabetes drug response predictor, and diabetes complications predictor) as well as overall experience. The score will be recorded on a 5-point Likert scale and the distribution of scores will express as a percentage of responses received. Free text comments will be analysed for emergent themes All outcomes measured at the end of the study period in addition to monthly interim analysis, as part of the Data and Safety Monitoring Board (DSMB) process | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. System usability measured using a combination of weekly questionnaires, qualitative data (free text questionnaire comments and semi-structured interviews) and validated questionnaire (system usability scale). Specific measures include: 1.1. Overall ease of use recorded on a 5-point Likert scale. The distribution of scores will be expressed as a percentage of responses received. 1.2. Free text comments and semi-structured interview transcripts will be analysed for emergent themes. 1.3. System Usability Scale to be administered at the end of the study period. 2. System usefulness measured using a combination of weekly questionnaires and qualitative data (free text questionnaire comments and semi-structured interviews). Specific measures include: 2.1. Clinical usefulness score recorded with a weekly questionnaire for each of the MWIQ features (diabetes sub-type predictor, diabetes drug response predictor, and diabetes complications predictor) as well as overall experience. The score will be recorded on a 5-point Likert scale and the distribution of scores will be expressed as a percentage of responses received. 3. System impact measured using a combination of routinely collected clinical data, system navigation data and weekly questionnaire data. Specific measures include: 3.1. Number of patients with the following care processes recorded within the past 12 months: HbA1c, blood pressure (BP), serum cholesterol, serum creatinine, urinary albumin, foot screening, Body Mass Index (BMI) and smoking status. The number of each will be expressed as a percentage of the total number of people with diabetes seen by participants within the study period. 3.2. Number of patients meeting the following treatment targets: HbA1c <58 mmol/mol, blood pressure =140/80 mmHg, cholesterol <5 mmol/l, as well as the number meeting all three targets. The number of each will be expressed as a percentage of the total number of people with diabetes seen by participants within the study | — |
Countries
England, United Kingdom