Evidence into Practice: evaluating a Child-centred intervention for diabetes medicine management

Completed

• Conditions: Type one diabetes; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN17551624
• Lead Sponsor: Cardiff University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br><br>Outcomes will be measured at baseline, 3 months (follow-up 1) and 6 months (follow-up 2).

Secondary Outcome Measures

Name	Time	Method
1. HbA1c<br>2. Generic quality of life<br>3. Routinely collected NHS/child-held data costs<br>4. Service use<br>5. Acceptability/utility<br><br>Outcomes will be measured at baseline, 3 months (follow-up 1) and 6 months (follow-up 2).