Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.shsrc.nhs.uk/

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

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23129571
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24908099

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

29/01/2016: Internal review.