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A patient decision aid to improve decision quality and health outcome in type 2 diabetic patients

The development and evaluation of the effectiveness of a patient decision aid to improve decision quality and health outcome in type 2 diabetic patients making treatment choices

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14842077
Enrollment
440
Registered
2010-06-24
Start date
2007-08-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Topic: Diabetes Research Network, Primary Care Research Network for England

Interventions

Current interventions as of 26/06/2012: Control Group: No PDA used by patients or doctors (usual care) Intervention Group: Brief training of clinicans pre-consultation, familiarisation of PDA by parti

Sponsors

Sheffield Health and Social Research Consortium
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes mellitus 2. Aged 21 years and above, either sex 3. HbA1c greater than 7.4% 4. On maximum dose of oral anti-diabetic drugs 5. Advised by the doctor or nurse to start insulin

Exclusion criteria

Exclusion criteria: 1. Taking insulin currently 2. Difficulty reading or understanding English 3. Chronic debilitating illness (e.g., visual, hearing or cognitive impairment) 4. Active mental illness 5. Participated in a clinical trial in the past 6 months

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure(s) as of 26/06/2012: Decisional conflict as an indicator of decisional quality post-consultation and glycaemic control after 6 months (HbA1c). Previous primary outcome measure(s) until 26/06/2012: Baseline and six-month clinical data will be provided by the practices from the medical records.

Secondary

MeasureTime frame
Current secondary outcome measure(s) as of 26/06/2012: Knowledge and realistic expectations of risks and benefits, post consultation. Previous secondary outcome measure(s) until 26/06/2012: 1. The outcome of decision making will be glycaemic control (HbA1c) and persistence with chosen option 2. The process of decision making will be measured using decision quality indicators

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026