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ISRCTN
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ISRCTN14842077
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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DRN150 (PANDAs)
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Serial number at source
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4677
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Study hypothesis
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PANDAs is a cluster randomised controlled trial which will be carried out to evaluate the clinical effectiveness of a patient decision aid (PtDA) in general practice. The PtDA has been developed by the researchers to help people with type 2 diabetes make an informed decision about starting insulin treatment.
This study will be conducted in Sheffield and surrounding areas, involving 30 general practices. Participants in the intervention group will use the PtDA followed by the usual consultation; the control group will only be receiving the consultation (usual care).
The main outcome measures are improvement in participants' decision quality (immediate) and HbA1c level (6 months later).
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Lay summary
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Ethics approval
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MREC approved on the 19th June 2007 (ref: 07/Q2308/53)
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Study design
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Single centre randomised interventional process of care and treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Type 2, Not Assigned; Disease: Diabetic Control, All Diseases, Not Applicable, Education, Insulin Initiation
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2007
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Anticipated end date
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01/10/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Planned sample size: 1440; UK sample size: 1440
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Interventions
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Control group: No PtDA for patients or doctors
Intervention group: PtDA, for doctors and patients
Follow-up length: 6 months
Study entry: other
Details: randomised according to clusters of practices
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Primary outcome measure(s)
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Baseline and six-month clinical data will be provided by the practices from the medical records.
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Secondary outcome measure(s)
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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
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Service Delivery and Organisation (SDO)
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Trial website
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Publications
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Contact name
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Dr
Chirk-Jenn
Ng
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Address
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Northern General Hospital
Herries Road
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City/town
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Sheffield
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Zip/Postcode
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S5 7AU
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Country
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United Kingdom
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Email
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C.Ng@sheffield.ac.uk
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Sponsor
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Sheffield Health and Social Research Consortium (UK)
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Address
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Fulwood House
Old Fulwood Road
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City/town
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Sheffield
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Zip/Postcode
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S10 3TH
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Country
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United Kingdom
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Sponsor website:
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http://www.shsrc.nhs.uk/
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Date applied
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24/06/2010
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Last edited
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24/06/2010
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Date ISRCTN assigned
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24/06/2010
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