Plain English Summary
Background and study aims
It is important that patients are given the opportunity to be involved in their diabetes care. Good communication between the doctor and the patient can help patients be more involved. The aim of our study is to explore if a pre-consultation booklet for people with type 2 diabetes can help patients and diabetes hospital doctors communicate better in the consultation and improve patient outcomes. The pre-consultation intervention booklet will encourage people to ask questions and provide them with their own personal clinical data and examples of questions they might like to ask during the consultation.
Who can participate?
People with type 2 diabetes aged 75 or under who are attending general diabetes outpatient clinics at the Diabetes Day Centre at the University Hospital Galway for review appointments will be approached to participate in the study.
What does the study involve?
Participants will be randomly allocated to one of three groups. The first group will receive an intervention booklet (containing personalised clinical information and prompt questions) at least 48 hours before their review appointment. The second group will receive a general information booklet (containing a glossary of diabetes topics usually discussed during a review visit) at least 48 hours before their review appointment. The third group will not receive a booklet. Those participating in the study will need to attend the Diabetes Day Centre 1-4 weeks before their review clinic appointment to have their HbA1c, cholesterol, blood pressure and Body Mass Index measured.
Participants will complete short questionnaires on a number of occasions including when they have their blood tests done at the beginning of the project, directly before and after their first and second review appointment, six weeks after their first and second appointment, and six months after their second review visit. Data from patients in the control, general information, and intervention groups will be compared to see if there are any differences in patient outcomes and in how patients and doctors communicate during the consultation.
What are the possible benefits and risks of participating?
Findings from our research study may help improve the way we deliver diabetes care in the future.
Where is the study run from?
The Diabetes Day Centre, University Hospitals Galway (Ireland).
When is study starting and how long is it expected to run for?
The study ran from January 2011 to January 2014.
Who is funding the study?
This project is funded by the Health Research Board (HRB) (Ireland).
Who is the main contact?
Dr Máire O Donnell
maire.odonnell@nuigalway.ie
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sean Dinneen
ORCID ID
Contact details
Clinical Science Institute
National University of Ireland Galway
University Road
Galway
-
Ireland
+353 91 495290
sean.dinneen@nuigalway.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Development and assessment of the feasibility, acceptability and potential effectiveness of a Patient Information Pre-consultation Package containing personalised clinical information for patients with type 2 diabetes attending an outpatient diabetes clinic for a review visit: a mixed methods approach (PIPP study)
Acronym
PIPP
Study hypothesis
The aim of this study is to design and evaluate a patient intervention to be given to type 2 diabetes patients prior to their outpatient review visit in order to facilitate their involvement in the consultation and to explore the effects of this information on clinical and psychosocial outcomes.
Specific objectives:
1. To develop a personalised clinical information sheet for patients with Type 2 diabetes informing them of the current status of their diabetes
2. To compare the administration of this personalised clinical information sheet during diabetes clinic attendance with administration of a non-personalised information sheet and with no administration (i.e. routine care)
3. To explore the feasibility of a large multi-centre trial evaluating this approach to diabetes care delivery in other diabetes clinics in Ireland
Ethics approval
1. Galway Regional Hospitals Research Ethics Committee, December 2010, ref: 11 January 2010
2. National University of Ireland Galway Research Ethics Committee, March 2011, ref: C.A.507
Study design
Exploratory randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
The intervention is a pre-consultation booklet that the intervention group will receive at least 48 hours before their review appointment. The intervention booklet will include personalised diabetes-related clinical information about their weight, body mass index, blood pressure and recent laboratory results including HbA1c and cholesterol levels. They will also receive prompt questions relating to their their personal clinical information and diabetes care. They will receive this intervention on two occasions at two consecutive clinic visits.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. HbA1c
2. Measure of diabetes self-efficacy
Secondary outcome measures
1. Patient anxiety
2. Patient satisfaction with the consultation
3. Weight
4. Cholesterol
5. Blood pressure
6. Self-care activities
7. Diabetes-related distress
Overall trial start date
05/01/2011
Overall trial end date
04/01/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. People with type 2 diabetes of at least 12 months duration
2. People with type 2 diabetes attending general diabetes outpatient clinics
3. People with type 2 who have had their blood tests done (HbA1c, lipids) within 8 weeks of recruitment into the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150 patients
Participant exclusion criteria
1. People with Type 1 diabetes
2. People with type 2 diabetes whose English language ability, literacy or cognitive function will not enable them to participate in the study
3. People with type 2 diabetes who have not had blood tests (HbA1c, lipids) done within 8 weeks of their outpatient visit
Recruitment start date
05/01/2011
Recruitment end date
04/01/2014
Locations
Countries of recruitment
Ireland
Trial participating centre
Clinical Science Institute
Galway
-
Ireland
Sponsor information
Organisation
Health Research Board (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin
2
Ireland
+353 1 234 5000
hrb@hrb.ie
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board (Ireland), ref: HRA_HSR/2010/19
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Ireland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2016 results in https://doi.org/10.1016/j.pec.2015.11.014 (added 21/01/2019)