Paediatric diabetes (type 1) Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Please note that, as of 16 January 2008, the start and anticipated end date of this trial have been updated from 1 April 2007 and 31 December 2008 to 1 June 2005 and 31 March 2009, respectively.
Int
Sponsors
Cardiff University (UK)
Eligibility
Inclusion criteria
Inclusion criteria: For teams/clinics: Teams include a paediatrician with an interest in diabetes and a diabetes specialist nurse For patients: 1. Type 1 diabetes 2. Aged 4-15 3. Under care of diabetes team for duration of trial 4. Diagnosed more than 1 year ago 5. Parental/guardian and child consent (or assent where appropriate) given 6. ability of patient and at least one parent/guardian to complete study materials (questionnaires) Children aged 4-15 will be included to reflect as broad a range of patients as possible. Young people aged 16+ may be in transition between paediatric and adult services at some point during the trial and are therefore excluded. Data collected from questionnaires is crucial to determining the effectiveness of the intervention. However, questionnaires are only available in English, as measures included have not been validated in other languages: this would be beyond the scope of the current study.;Inclusion criteria: For teams/clinics: Teams include a paediatrician with an interest in diabetes and a diabetes specialist nurse For patients: 1. Type 1 diabetes 2. Aged 4-15 3. Under care of diabetes team for duration of trial 4. Diagnosed more than 1 year ago 5. Parental/guardian and child consent (or assent where appropriate) given 6. ability of patient and at least one parent/guardian to complete study materials (questionnaires) Children aged 4-15 will be included to reflect as broad a range of patients as possible. Young people aged 16+ may be in transition between paediatric and adult services at some point during the trial and are therefore excluded. Data collected from questionnaires is crucial to determining the effectiveness of the intervention. However, questionnaires are only available in English, as measures included have not been validated in other languages: this would be beyond the scope of the current study.
Exclusion criteria
Exclusion criteria: For teams/clinics: <40 potentially eligible children/adolescents (diagnosed more than 1 year ago) attending the clinic For patients: 1. Not under care of parent or guardian (i.e. a looked after child) 2. Co-morbid chronic illness likely to impact on HbA1c independent of patient's ability to manage their diabetes (e.g. condition requiring steroid treatment, cystic fibrosis, renal failure) 3. In receipt of ongoing psychiatric/psychological therapy at the start of the study 4. Other patients judged by their clinical carer to be vulnerable due to existing medical or social condition Criteria have been designed in order to be as inclusive as possible. Clinics with less than 40 patients will be excluded due to practicalities of recruiting sufficient patient numbers (30 per clinic) and fewer than 40 patients is not felt to constitute an adequate size for a specialist children's service. It is unfortunately not feasible to recruit children under a care order, due to the practical difficulties of obtaining appropriate consent: this is felt to be outside the scope of the current study. However, patients attending clinics where health professionals have undergone training are likely to benefit from increased awareness of psychosocial issues.;Exclusion criteria: For teams/clinics: <40 potentially eligible children/adolescents (diagnosed more than 1 year ago) attending the clinic For patients: 1. Not under care of parent or guardian (i.e. a looked after child) 2. Co-morbid chronic illness likely to impact on HbA1c independent of patient's ability to manage their diabetes (e.g. condition requiring steroid treatment, cystic fibrosis, renal failure) 3. In receipt of ongoing psychiatric/psychological therapy at the start of the study 4. Other patients judged by their clinical carer to be vulnerable due to existing medical or social condition Criteria have been designed in order to be as inclusive as possible. Clinics with less than 40 patients will be excluded due to practicalities of recruiting sufficient patient numbers (30 per clinic) and fewer than 40 patients is not felt to constitute an adequate size for a specialist children's service. It is unfortunately not feasible to recruit children under a care order, due to the practical difficulties of obtaining appropriate consent: this is felt to be outside the scope of the current study. However, patients attending clinics where health professionals have undergone training are likely to benefit from increased awareness of psychosocial issues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure for patients is glycaemic control assessed using HbA1c at 1 year. ;The primary outcome measure for patients is glycaemic control assessed using HbA1c at 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| For diabetes care teams: 1. Competency in delivery of the psychosocial intervention immediately, 3 months and 1 year post training 2. Importance and confidence in conducting behaviour change discussions during consultations (before and after training and at 1 year) 3. Systemic service changes (including consultation times, and telephone/home contacts) Clinical outcomes for patients at each clinic visit: 1. Height, weight, Body Mass Index (BMI) 2. Insulin type, dose and number of injections 3. Hypoglycaemic episodes Psychosocial outcomes for patients at study entry and 1 year: 1. Diabetes-specific quality of life (Pediatric Quality of Life Inventory [PEDSQoL diabetes module]; Problem Areas in Diabetes [PAID: emotional impact]; global quality of life measure) 2. Diabetes self-care (items relating to mis-management) 3. Self-efficacy (perceived competency scale) 4. Patient enablement (coping) 5. Perceptions of diabetes care team (Health Care Climate Questionnaire [HCCQ]; items relating to communication between clinicians, feelings towards next visit, continuity of care) 6. Preferences for care (as measured by a Discrete Choice Experiment) Psychosocial outcomes for parents/guardians at study entry and 1 year: 1. Parent quality of life/anxiety (Problem Areas in diabetes; global quality of life item) 2. Perceptions of diabetes team (HCCQ: items relating to communication between clinicians, feelings towards next visit, continuity of care) 3. Preferences for care (Discrete Choice Experiment) Parent-completed proxy measures (for children aged 5-11): 1. Diabetes specific quality of life (PEDSQoL diabetes module; Problem Areas in Diabetes; global quality of life item) 2. Diabetes self care (mis-management) Service use and cost outcomes: 1. Cost of intervention (including training) 2. Travel to clinic 3. School absences 4. Time off work (parent) 5. In-patient admissions (including Intensive Therapy Unit [ITU] and High Dependency Unit [HDU], particularly with ketoacidosis) 6 | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed