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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN17551624 |
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Date of registration:
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23/06/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evidence into Practice: evaluating a Child-centred intervention for diabetes medicine management
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Scientific title:
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Date of first enrolment:
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01/02/2009 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN17551624 |
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Study type:
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Interventional |
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Study design:
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Pragmatic randomised controlled trial (Quality of life)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Anne
Williams |
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Address:
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Nursing, Health and Social Care Research Centre
School of Nursing & Midwifery Studies
Eastgate House
35-43 Newport Road
CF24 0AB
Cardiff
United Kingdom |
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Telephone:
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+44 (0)29 2091 7816 |
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Email:
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awglanrhyd@aol.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children aged 6 - 18 years, either sex
2. Type one diabetes
Exclusion criteria: 1. Severe learning difficulties
2. Significant social problems
3. Needle phobias
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type one diabetes
Nutritional, Metabolic, Endocrine
Insulin-dependent diabetes mellitus
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Intervention(s)
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The investigation is a mixed-method study informed by the 'Promoting Action on Research Implementation in Health Services' (PARIHS) framework which has been widely used to inform design and evaluation of evidence-into-practice initiatives.
To meet our objectives which are aligned with the phases of the Medical Research Council (MRC) framework for randomised controlled trials (RCTs) of complex interventions we have designed a four-stage study:
Stage 1: Review and, where appropriate, undertake further work to identify types/formats of information most likely to assist age-appropriate decision-making/choices related to children/young people with type one diabetes. Duration: April 2008 to October 2008.
Stage 2: Construct an exemplar information resource, piloting for variations as necessary. Duration: November 2008 to October 2009.
Stage 3: Conduct a pragamatic evaluation to assess utility, acceptability effectiveness and cost effectiveness of the information resource. Duration: November 2009 to June 2010.
Stage 4: Undertake data synthesis and comparative analysis. Duration: July 2009 to March 2011.
The intervention lasts for 8 months with a follow-up at 3 months from baseline and 3 months from first follow-up.
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Primary Outcome(s)
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Choice of outcomes is guided by Health Technology Assessment (HTA) commissioned systematic reviews recommending that HbA1c (glycaemic control measure) is not the appropriate primary outcome on which to assess benefits of an intervention designed to more directly effect behaviour/self-management. Therefore, the primary outcome measure is diabetes self-efficacy and quality-of-life using the Diabetes Pediatric Quality of Life Inventory (PedsQol).
Outcomes will be measured at baseline, 3 months (follow-up 1) and 6 months (follow-up 2).
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Secondary Outcome(s)
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1. HbA1c
2. Generic quality of life
3. Routinely collected NHS/child-held data costs
4. Service use
5. Acceptability/utility
Outcomes will be measured at baseline, 3 months (follow-up 1) and 6 months (follow-up 2).
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Source(s) of Monetary Support
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National Institute for Health Research (NIHR) (UK) - Service Delivery and Organisation (SDO) Programme (ref: 0001653)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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