Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2021
INTERVENTION: There will be four sub‐studies: Sub‐study A: Randomised feasibility study. Sub‐study B: Semi‐structured interviews with patients on study acceptability and glycaemic target‐setting. Sub‐study C: Semi‐structured interviews with healthcare professionals on glycaemic‐target setting. Sub‐study D: Semi‐structrued interviews with patients on barriers to participation. STUDY PROCESSES In the feasibility study, participants will be randomised (stratified [Type 1 or Type 2 diabetes], random permuted block randomisation strategy) to one of two groups. After initial screening and run‐in, participants will be reviewed at three months for intervention delivery and six months for follow‐up. Semi‐structured interviews will be carried out with a sample of patients and healthcare professionals to explore experiences, views and opinions of participants on the acceptability of study processes, glycaemic target‐setting and barriers to participation. INTERVENTION Following a three‐month run‐in period, group one will have an explicit HbA1c target set 5 mmol/mol above their current HbA1c reading. Group two will have an explicit HbA1c target set 5 mmol/mol below their current HbA1c reading. Diabetes treatment of participants will not be altered. A series of validated psychmetric questionnaires will evaluate baseline (pre‐intervention) and follow‐up (three months post‐intervention) metrics of 'health‐related quality of life', 'diabetes‐related distress', 'wellbeing', 'empowerment' and 'self‐care'. CONDITION: Type 1 and Type 2 diabetes ; Nutritional, Metabolic, Endocrine ; Diabetes mellitus PRIMARY OUTCOME: ; Sub study A:; 1. Eligibility rate recorded as number of screened patients who were eligible against inclusion/exclusion criteria per month.; 2. Recruitment rate recorded as number of eligible patients who consented to participate in the study by 4 months.; 3. First follow‐up retention rate recorded as the number of participants who consent to participate and remain in the study until first follow‐up at 3 months.; 4. Last follow‐up retention rate recorded as the number of participants who consent to participate and remain in the study until the final study visit at 6 months.; 5. Response rate of the 3‐month and 6‐month psychometric questionnaires, recorded as the number of participants who consent to participate who fully complete the questionnaires pre‐ (3 months) and post‐intervention (6 months).; INCLUSION CRITERIA: Sub‐study A: 1. Aged 18 and over. 2. Has Type 1 or Type 2 Diabetes. 3. HbA1c >/=64; =125 mmol/mol. Sub‐study B: 1. enrolled in study A. Sub‐study C: 1. Healthcare professional directly involved in the care of people with diabetes. Sub‐study D: 1. Eligible patients declining entry into sub‐study A will be approached for inclusion in study D. SECONDARY OUTCOME: ; Sub‐study A:; 1. Health‐related quality of life, measured using the EuroQoL 5D‐5L (EQ‐5D‐5L) questionnaire, pre‐ (3 months post‐randomisation) and post‐intervention (6 months post‐randomisation).; 2. Diabetes‐related distress, measured using the Problem Areas in Diabetes (PAID), pre‐ (3 months post‐randomisation) and post‐intervention (6 months post‐randomisation).; 3. Self‐care in diabetes, measured using the Summary of Diabetes Self‐care Activities (SDSCA), pre‐ (3 months post‐randomisation) and post‐intervention (6 months post‐randomisation).; 4. Wellbeing, measured using the Well Being Questionnaire‐12 (WBQ‐12), pre�� (3 months post‐randomisation) and post‐intervention (6 months post‐randomisation).; 5. Diabetes empowerment, measured using the Diabetes Empowerment Scale‐Long Form (DES‐LF), pre‐ (3 months post‐randomisation) and post‐intervention (6 months post‐randomisation).; 6. Glycaemic control, measured using point‐of‐care glycated haemoglobin (HbA1c) at baseline, 3 months and 6 months.; 7. Clinical outcomes such as height, weight and blood pressure at baseline, 3 months and 6 months.; Sub‐study B:; 8. Semi‐structured interviews with participants enrolled in sub‐study A during the trial period at a convenient time for participants. Interviews will be transcribed and analysed using the framework method of content analysis.; Sub‐study C:; 9. Semi‐structured interviews with healthcare professionals during the trial period at a convenient time for participants. Interviews will be transcribed and analysed using the framework method of content analysis.; Sub‐study D:; 10. Semi‐structured interviews with patients who declined to enrol in sub‐study A during the trial period at a convenient time for participants. Interviews will be transcribed and analysed using the framework method of content analysis.;
Epistemonikos ID: 453a38c0e8a96bb2a81c3052c944f88b88660e5f
First added on: Aug 25, 2024