Maximising engagement, motivation and long-term change in a structured intensive education programme in diabetes for children, young people and their families: Child and Adolescent Structured Competencies Approach to Diabetes Education

ISRCTN	ISRCTN52537669
DOI	https://doi.org/10.1186/ISRCTN52537669
Secondary identifying numbers	HTA 06/44/05

Submission date: 08/10/2007
Registration date: 08/10/2007
Last edited: 13/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Managing diabetes within a full and active life is challenging for both children and young people. Despite parental support and 'expert' education many children and young people struggle to control their diabetes. Combining educational and psychological approaches can achieve long term-change, particularly in young people with poorly controlled diabetes who have not responded to other approaches. Children, young people and families have been involved in developing a structured psycho-educational programme with the UCLH diabetes teams. Four monthly group sessions will be offered to 3-4 similarly aged young people (and parents). The aim is to develop confidence in the use of flexible self-management approaches, including how to adapt the amount of insulin given, eat normally and manage daily challenges (e.g. exercise, illness, and holidays). The programme is acceptable to a broad range of families and can be delivered within a busy clinical service. For 170 families attending our clinics there has been a steady and consistent improvement in diabetes control that is maintained over time.

Who can participate?
Children and young people (aged 8-16) and their families from 26 participating clinics

What does the study involve?
Clinical Nurse Specialists at 13 randomly chosen clinics attend training workshops. Children and young people and their families from the participating clinics are invited to participate in the programme and a two-year follow-up. We assess how acceptable the programme is, ease of delivery, participation and impact on health-related quality of life, self-management behaviour, emotional, behavioural and family functioning, and service use. The costs of the programme are compared to the economic impact of improvements in diabetes control and reduced risk of long-term complications.

What are the possible benefits and risks of participating?
In the short term, improving participants’ control of their diabetes may also improve general well-being. In the longer term improvement in diabetes control may reduce their later risk of complications of diabetes. There are no risks involved in the study.

Where is the study run from?
University College London Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2008 to December 2012

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Deborah Christie
Deborah.Christie@uclh.nhs.uk

Study website

Contact information

Dr Deborah Christie
Scientific

Dept of Child and Adolescent Psychological Services
6th Floor, Central
250 Euston Rd
London
NW1 2PG
United Kingdom

Phone	+44 (0)20 7380 9086
Email	Deborah.Christie@uclh.nhs.uk

Study information

Study design	Multi-centre cluster randomised control trial with integral process and economic evaluation
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	http://cascade.lshtm.ac.uk/information.html
Scientific title	Maximising engagement, motivation and long-term change in a structured intensive education programme in diabetes for children, young people and their families: Child and Adolescent Structured Competencies Approach to Diabetes Education
Study acronym	CASCADE
Study objectives	There is a significant increase in the number of children and young people diagnosed with diabetes. The current estimate of prevalence in the UK is 1 per 700 - 1000 children yielding a total population aged under 25 of approximately 15,000 - 25,000. The peak age for diagnosis is between 10 and 14 years of age. The long-term complications of diabetes include microvascular and macrovascular disease, reduced life and higher cardiovascular and all-cause mortality. Complications are often first detected in adolescence. Improved diabetes control from diagnosis in childhood can reduce the incidence and progression of microvascular complications including retinopathy, nephropathy and neuropathy. Overall metabolic control in children and adolescents has improved little in the UK in the past decade. Only 14 - 20% of children and young people with type 1 diabetes meet the recommended HbA1c of less than 7.5%. CASCADE, is a competency-driven, motivational and patient-centred structured intensive psycho-educational programme specifically designed by our team to improve diabetic control, self-management and quality of life in children and adolescents. CASCADE is a complex intervention and our proposed investigation is based on the Medical Research Council (MRC) complex intervention evaluation framework. We have already conducted the Phase I study (Modelling - defining components of the intervention) and Phase II study (Exploratory Trial Phase). We now propose a Phase III large multi-centre cluster randomised controlled trial with integral process and economic evaluation to investigate the effectiveness of CASCADE. Our extensive experience in teaching and training will be used to identify the time and resources required to train members of the study centres which will be incorporated into the economic modelling process. Research objectives: 1. To assess the feasibility of the proposed structured intensive educational programme provided within a standard clinic setting for a diverse range of young people 2. To investigate the effects of the above intervention on long term metabolic control of diabetes 3. To evaluate the impact of the intervention on diabetes-specific quality of life using: 3.1. Well validated and reliable self report and parental measures of quality of life in children and young people 3.2. Specific measures of parental quality of life 4. To investigate the impact of the intervention on psychosocial functioning including: 4.1. Emotional and behavioural adjustment of children and young people 4.2. Family functioning 4.3. Self-management, decision making and self-efficacy 5. To investigate the cost effectiveness of the intervention More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/064405 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0017/51443/PRO-06-44-05.pdf
Ethics approval(s)	The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A), 11/07/2007, ref: 07/H0714/112
Health condition(s) or problem(s) studied	Diabetes
Intervention	Structure of CASCADE intervention: The intervention is delivered in 4 group sessions, delivered monthly over a 4 month period. Children will be grouped by age (either 8 -11 or 12 -16 years) and participate in groups with 3 - 4 families per group. A developmentally appropriate curriculum supports flexible self-management in partnership with the young person, their diabetes regimen and their family. The programme focuses on achievement of increasing competency in self-management of diabetes using eight competency levels. The Kaufman competencies were developed at the Childrens Hospital, Los Angeles as an 8-stage competency system surrounding diabetes knowledge and skills (including adaptation of insulin dosage, carbohydrate counting and management of daily challenges (e.g., exercise, illness and/or holidays). This system was developed to assess suitability for intensive therapy using Continuous Subcutaneous Insulin Infusion (CSII), but is applicable to all current insulin regimens. The competency level of each child can be used to ensure that the psycho-educational programme is delivered in a flexible and developmentally appropriate manner. Components of CASCADE: CASCADE is consistent with the five key criteria necessary to fulfill the National Institute for Clinical Excellence (NICE) requirements for a structured diabetes education programme. These are patient centred philosophy, structured curriculum, trained educators, quality assured and audited. CASCADE module content: Module 1: Living with diabetes - challenges and choices Module 2: Blood sugar testing - the pros and cons Module 3: Adjusting insulin doses - the pros and cons Module 4: HELP with food, activity and exercise - a Healthy Eating Lifestyle Plan Each module will include the following educational and motivational structure: 1. Identify learning objectives: Trainers invite families to identify recent aspects of diabetic management that have gone well to encourage them to see themselves as experts in their diabetes and to help them identify strengths, resources and abilities. Participants are encouraged to identify what they would find useful or helpful to discuss and think about during the session. This ensures that participants collaborate in the identification of learning objectives 2. Addressing ambivalence: Desired behaviour change choices are discussed using motivational enhancement techniques that address ambivalence. Participants identify the pros and cons of behaviour change acknowledging that any change in behaviour will have both costs and benefits. Motivational interviewing focuses on encouraging the individual to identify the personal and systemic benefits of the desired behaviour to them and their family 3. Externalising: Externalising language encourages participants to characterise the diabetes as something that is external to the individual and therefore controllable. This creates opportunities for young people and families to work with the health care professionals by identifying ways to take control of diabetes rather than it being something that controls them Pre and post session knowledge will be evaluated as well as inviting feedback on how useful and helpful the session has been and what actions the young person plans to initiate in between sessions. Control arm: Control families will continue to receive standard care from their clinical team, being regular 3-monthly clinic visits and telephone contact as required with the clinical nurse specialist and consultant. The process evaluation will monitor and describe standard care as well as the new intervention being tested.
Intervention type	Other
Primary outcome measure	Change in HbA1c between baseline and 12 months after intervention. NB. It is not possible to directly evaluate the effects of the intervention on diabetes complications because of low incidence during adolescence.
Secondary outcome measures	1. HbA1c at 24 months: the HbA1c measurement at 24 months post intervention will be examined as a secondary outcome assessing maintenance of effect 2. Economic evaluation: this will include within-trial cost-effectiveness analysis and a cost-utility analysis based on a model combining data from the trial with data from the literature. The perspective adopted will be that of the NHS, that is, the economic evaluation will only consider costs to the NHS and health benefits to patients 3. Psychosocial outcomes (using validated instruments appropriate for age): 3.1. Health related Quality Of Life (QOL): PedsQL with Diabetes module 3.2. Self-Efficacy in Diabetes scale 3.3. Diabetes Family Responsibility Questionnaire 3.4. Strengths and Difficulties Questionnaire (parent and child report versions) 4. Diabetes outcomes directly related to patient management: 4.1. Kaufman Competency level 4.2. Diabetes regimen (insulin delivery/number of injections/insulin types) 4.3. Hypoglycaemic episodes (frequency, severity) 4.4. Admissions to Hospital and reason (e.g. episodes of ketoacidosis, hypoglycaemia) 5. Diabetes outcomes indirectly related to patient management: knowledge and skills associated with diabetes 6. Compliance with intervention/control: 6.1. Attendance at intervention sessions 6.2. Service utilisation rate 6.3. Clinic attendance 6.4. Number of contacts with diabetes nurse specialists and diabetes teams Process evaluation: The study will incorporate an integral process evaluation, similar to other trials conducted by Social Service Research Unit (SSRU). The overall aims of this will be to: 1. Monitor the implementation (including extent of uptake) of the intervention in experimental clinics and any alternative intervention received by young people and families attending control clinics 2. Document factors influencing the implementation of the intervention 3. Identify components of the intervention which contribute to its effectiveness 4. Assess the acceptability of the interventions to young people, parents and clinic staff 5. Examine perceived impact of the intervention on outcomes Specific issues that will be addressed include: 1. The quality of training for clinic staff and satisfaction with this 2. The extent to which the sessions with young people and families are delivered as intended and according to underlying principles and theories (e.g. patient centred and non didactic, motivational and solution focused), barriers and facilitating factors to the uptake and engagement with the different components of the sessions by young people and families (e.g. structural such as timing of sessions, accessibility of clinics, and interpersonal such as views about relevance of content, qualities of educators) 3. Perceived impact of the sessions on management of the condition by young people and their parents. This might include examining how decisions are made and responsibilities for different aspects of the condition-management are shared, including transfer of responsibilities and changing patterns of self-care by the young person in different contexts (e.g. during school time, at home) 4. Issues such as whether interventions should be targeted for different age groups, for the different disease stages, or for young people with different types of diabetes management problems will also be explored
Overall study start date	01/05/2008
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	28 clinics, 308 children and young people
Key inclusion criteria	Current inclusion criteria as of 16/10/2012: 1. Subjects 8 - 16 years with type 1 diabetes 2. HbA1c greater than or equal to 8.5 (defined as mean 12 month HbA1c greater than or equal to 8.5%) 3. Cared for in participating paediatric and adolescent diabetes clinics (defined as clinic specific for paediatric and/or adolescent diabetes conducted by a specialist or general paediatrician with an interest in diabetes) An average of 40 - 50 young people per clinic will be eligible to take part in the study with an expected recruitment rate of 25% based on our pilot study. Previous inclusion criteria until 16/10/2012: An average of 80 - 100 young people per clinic will be eligible to take part in the study with an expected recruitment rate of 25% based on our pilot study.
Key exclusion criteria	1. Subjects with significant mental health problems unrelated to diabetes that require specific mental health treatment 2. Subjects with significant other chronic illness in addition to diabetes that may confound the results of the intervention 3. Subjects with significant learning disability or lack of command of English sufficient to render them unable to participate effectively in the planned intervention. Note that there is research evidence from this population that the great majority of eligible young people from black or minority ethnic groups in this population have good command of English, although their parents may not. Given the wide range of ethnicities in the sample population, and given the importance of group dynamics to the intervention, it will not be possible to use interpreters to enable parents with poor English to participate. We will ensure that the validity of the study is maintained by the following: 3.1. Young people with good command of English but whose parents have poor command of English will be eligible to attend by themselves if they wish 3.2. Another relative who is one of the primary diabetes carers (e.g. sibling, aunt or uncle) who has good command of English may participate instead of the parents While inclusive elsewhere, we will not recruit clinics that are unlikely to be able to recruit sufficient participants with a good command of English. We anticipate that this pertains to only one clinic within our sample area.
Date of first enrolment	01/05/2008
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London Hospital

London
NW1 2PG
United Kingdom

Sponsor information

University College London Hospital (UK)
Hospital/treatment centre

c/o Mr Nick McNally
Research and Development Directorate (Maples House)
Rosenheim Wing, Ground Floor
25 Grafton Way
London
WC1E 5DB
England
United Kingdom

Email	Nick.McNally@uclh.nhs.uk
Website	http://www.uclh.nhs.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	15/09/2009	Yes	No
Results article	results	01/03/2014	Yes	No
Results article	results	01/06/2016	Yes	No

Editorial Notes

13/06/2016: Publication reference added.

12/05/2016: Plain English summary added.

16/10/2012: the following changes were made to the trial record:
1. The overall trial end date of the study was changed from 30/04/2012 to 31/12/2012.
2. The target number of participants was updated from 26 clinics, 570 children and young people, to 28 clinics, 308 children and young people.

24/08/2009: the overall trial start and end dates were changed from 01/11/2007 and 31/10/2011 to 01/05/2008 and 30/04/2012, respectively.