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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17551624
Enrollment
200
Registered
2008-06-23
Start date
2009-02-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type one diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

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

Sponsors

Cardiff University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 6 - 18 years, either sex 2. Type one diabetes

Exclusion criteria

Exclusion criteria: 1. Severe learning difficulties 2. Significant social problems 3. Needle phobias

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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).

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026