Plain English Summary
Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). A large number of sufferers have poorly controlled blood sugar despite lifestyle changes and glucose lowering drug. This can lead to serious complications such as problems with the eyes (retinopathy), nerves (neuropathy) and kidneys (nephropathy), as well as significantly increasing the risk of heart problems. To control the blood sugar, a patient needs to either take insulin or another medication (e.g. glitazone). Patients often find it difficult to decide whether or not to start insulin for many reasons, such as lack of understanding or reluctance to inject themselves. Patient decision aids (PDAs) are specially designed resources which provide information to help people to make decisions. They have been shown to improve knowledge, help patients to understand treatment risks and benefits, address their values and roles in decision making. Few studies, however, have been able to show the impact of PDAs on patient’s health. The aim of this study is to find out whether a specially designed PDA for patients with T2DM can help more patients to make informed decisions about whether to start insulin therapy.
Who can participate?
Adults with poor blood sugar control, who are taking the maximum dose of anti-diabetic tablets.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive usual care from their doctors, and are not given access to the PDA. Those in the section group are given a run through of how to use the PDA, which is then available for them to use. At the start of the study and then again after 6 months, all participants have their blood sugar tested to find out if their control over their blood sugar (glycaemic control) has improved. Participants are also asked to complete questions in order to find out whether their current treatment is different to when the study started.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Northern General Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2008 to May 2015
Who is funding the study?
1. National Institute for Health Research (UK)
2. South Yorkshire Collaborative Local Research Network (UK)
Who is the main contact?
Professor Nigel Mathers
Trial website
http://www.sheffield.ac.uk/medicine/research/aupmc/pandas/about/index
Contact information
Type
Scientific
Primary contact
Prof Nigel Mathers
ORCID ID
Contact details
Academic unit of Primary Medical Care
University of Sheffield
Samuel Fox House
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 114 222 2099
s.l.hart@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4677
Study information
Scientific title
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
Acronym
DRN150 (PANDAs)
Study hypothesis
Current study hypothesis as of 23/07/2012:
The use of the PANDAs patient decision aid improves decision quality in patients with type 2 diabetes mellitus who are making a decision whether or not to start insulin in General Practice.
PANDAs is a cluster randomised controlled trial which has been carried out to evaluate the clinical effectiveness of a patient decision aid (PDA) in general practice. The PDA has been developed by the researchers to help people with type 2 diabetes make an informed decision about starting insulin treatment.
Previous study hypothesis as of 26/06/2012:
PANDAs is a cluster randomised controlled trial which will be carried out to evaluate the clinical effectiveness of a patient decision aid (PDA) in general practice. The PDA has been developed by the researchers to help people with type 2 diabetes make an informed decision about starting insulin treatment.
This study was conducted in South Yorkshire, UK, involving 49 general practices. Participants in the intervention group used the PDA followed by the usual consultation; the control group received the consultation (usual care).
The main outcome measures were improvement in participants decision quality (immediate) and HbA1c level (6 months later).
Original study hypothesis:
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).
On 26/06/2012 the following changes were made to the trial record:
1. The public title was updated. The previous public title was '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'.
2. The anticipated end date was changed from 01/10/2010 to 28/02/2011.
3. The target number of participants was changed from 1440 to 440.
4. The sources of funding field was updated. The previous text was 'National Institute for Health Research (NIHR) (UK) - Service Delivery and Organisation (SDO)'.
Ethics approval
North Sheffield Research Ethics Committee, 19/06/2007, ref: 07/Q2308/53
Study design
Single-centre randomised interventional process of care and treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Intervention
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 participants, use of PDA by patients and clinicians
Follow-up length: 6 months
Study entry: other
Details: randomised according to clusters of practices
Previous interventions until 26/06/2012:
Control group: No PtDA for patients or doctors
Intervention group: PtDA, for doctors and patients
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 outcome measures
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
Overall trial start date
01/08/2007
Overall trial end date
28/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
440 participants from 49 GP surgeries across South Yorkshire
Participant 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
Recruitment start date
01/08/2007
Recruitment end date
28/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern General Hospital
Academic unit of Primary Medical Care
Samuel Fox House
Herries Road
Sheffield
S5 7AU
United Kingdom
Sponsor information
Organisation
Sheffield Health and Social Research Consortium
Sponsor details
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
South Yorkshire Collaborative Local Research Network (SY CLRN)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
30/06/2012
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23129571
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24908099
Publication citations
-
Results
Mathers N, Ng CJ, Campbell MJ, Colwell B, Brown I, Bradley A, Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice., BMJ Open, 2012, 2, 6, doi: 10.1136/bmjopen-2012-001469.
-
Results
Brown I, Bradley A, Ng CJ, Colwell B, Mathers N, Investigating active ingredients in a complex intervention: a nested study within the Patient and Decision Aids (PANDAs) randomised controlled trial for people with type 2 diabetes., BMC Res Notes, 2014, 7, 347, doi: 10.1186/1756-0500-7-347.