Plain English Summary
Background and study aims
Diabetes is a lifelong (chronic) condition that causes a person's blood sugar level to become too high. A survey found that although 80% of patients with type 2 diabetes say they are well informed, 71% would like other additional information. Only 17% of the same patients report receiving instruction in addition to their treatment. Pharmacists could exert a major effect on treatment adherence in chronic disease. The aim of this study to assess the impact of information provided by community pharmacists on patients’ adherence to treatment.
Who can participate?
Patients aged over 18 with type 2 diabetes
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group attend interviews with a pharmacist three times over 6 months (once every 2 months) covering diet, drug treatment and the complications of diabetes. Each interview lasts about thirty minutes and involves general monitoring of the patient and then giving the patient a brochure which is an opening for a discussion between the pharmacist and the patient. Participants in the other group receive treatment as usual. The impact on treatment adherence is assessed in both groups after 6 months by the pharmacist counting the tablets remaining in the treatment packs delivered to the patient during the previous visit.
What are the possible benefits and risks of participating?
The benefits for the patient are a better knowledge of diet and the complications of diabetes, as well as better management of their treatment. There are no expected risks for the participants.
Where is the study run from?
182 pharmacies in France
When is the study starting and how long is it expected to run for?
March 2014 to December 2016
Who is funding the study?
Merck (USA)
Who is the main contact?
Dr Yves Michiels
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
012014
Study information
Scientific title
Impact of a community pharmacy based information program on type 2 diabetic patients' adherence to their oral treatment (IPhODia): a randomized cluster study vs usual practice
Acronym
IPhODia
Study hypothesis
Diabetes is a prime example of a chronic disease which is increasingly prevalent in France (38% in 7 years) and accounts for nearly 10% of our health spending. The many complications associated with diabetes contribute substantially to this spending and occur when diabetes is insufficiently controlled. The current therapeutic objective of the treatment is measured by the level of Hba1C which should be < 7% as defined by NHANES.
In France, despite significant improvements in the follow up of type 2 diabetes patients, the last results of Entred 2007-2010 are showing an insufficient level of control with too many patients with HbA1C>7%. This epidemiological study points to improved control of cardiovascular risk factors (lipid profile, high blood pressure) but still inadequate control of glycaemia. Some 41% of people with type 2 diabetes have HbA1c levels above 7% and 15% have levels above 8%.
These figures, testifying to failed therapy, are the source of many hospitalizations especially as glycaemic balance is not achieved. Alongside this, the costs of cover are proportional to this absence of control. The annual cost of a diabetic patient rises from $2 792 for an HbA1c < 7% to $6 759 for an HbA1c of 10%. Several additional measures should be contemplated to make therapy more efficacious. Adherence or rather non-adherence is inherent in chronic drug treatment and for diabetes, many studies are increasingly highlighting adherence as a factor for successful or unsuccessful drug treatment. Adherence seems to be one of the key points for the successful treatment of a chronic diseases like diabetes.
General practitioners remain the prime point-of-contact for diabetic patients, in spite of regular controls, physicians encounter difficulties correctly informing their patients mainly due to a lack of time and means. Diabetic patients must, in the majority (90%) of cases, go to the pharmacy for their treatment to be renewed and dispensed. This should be a useful opportunity for detecting and correcting any decline in adherence. Pharmacists, who are par excellence specialists in medication, are an essential actor and thanks to their expertise, their large number and their accessibility, pharmacists could play a beneficial role in patient adherence.
The IPhODia study aims to assess the impact on adherence of specific information provided by community pharmacists.
Ethics approval
In France a clinical trial such as IPhODia does not require ethics approval
Study design
Prospective multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Diabetes
Intervention
The intervention consists of three different pharmaceutical interviews during 6 months (one every 2 months) covering thematic information on diabetes, namely diet for diabetics, monitoring drug treatment and the complications of diabetes. Each interview is composed of two parts and lasts about 30 minutes. It involves first general monitoring of the diabetic patient and then giving the patient a thematic information brochure which is an opening for a discussion between the pharmacist and the patient.
In order to demonstrate the effectiveness of this intervention, a randomised study is performed with two groups of patients, one receiving information from the pharmacists according to the program, the other receiving treatment as usual. Impact on adherence will be assessed using the Medication Possession Ratio (MPR) at 6 months.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Medication Possession Ratio (MPR), measured by the pharmacist by counting tablets remaining in the treatment packs delivered to the patient during the previous visit, at 6 months
Secondary outcome measures
1. HbA1c level, measured by laboratory analysis at 6 months
2. Adherence, measured by a specific questionnaire (TOP) at 6 months
3. Patient’s knowledge acquisition, measured by a specific questionnaire developed by the scientific committee at 6 months
4. Patient’s satisfaction, measured by a specific questionnaire developed by the scientific committee, for the patients in group A at 6 months
Overall trial start date
01/03/2014
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men or women
2. Age >18 years
3. Diabetics with less four oral antidiabetics medications
4. HbA1c> 6.7%
5. Patient present at pharmacy for more than 6 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant exclusion criteria
1. Cancer
2. Patients with insulin treatment or anti-diabetics injectables
Recruitment start date
01/03/2014
Recruitment end date
01/09/2016
Locations
Countries of recruitment
France
Trial participating centre
PHARMACIE NGHIEM
91600
Trial participating centre
PHARMACIE BONNET
34000
Trial participating centre
PHARMACIE GOULET
76620
Trial participating centre
PHARMACIE SUEUR
80230
Trial participating centre
PHARMACIE HENRY
18120
Trial participating centre
PHARMACIE BOUDON
15120
Trial participating centre
PHARMACIE BERTHOLOM
29910
Trial participating centre
PHARMACIE LAIR-MARTIN-LONGUESSERRE
31260
Trial participating centre
PHARMACIE STAHL
88290
Trial participating centre
PHARMACIE BERTOUX-FORESTIER
80134
Trial participating centre
PHARMACIE BERA
38114
Trial participating centre
PHARMACIE DERAM
62220
Trial participating centre
PHARMACIE RENUCCI
84210
Trial participating centre
PHARMACIE SCHAUB
73230
Trial participating centre
PHARMACIE GERMES-CANEPA
35300
Trial participating centre
PHARMACIE LOUBRIEU
49240
Trial participating centre
PHARMACIE OSTER-HILD
67400
Trial participating centre
PHARMACIE LAFORTUNE
91390
Trial participating centre
PHARMACIE BIZON
49280
Trial participating centre
PHARMACIE VAURY
91670
Trial participating centre
PHARMACIE THOUVEREY
71500
Trial participating centre
PHARMACIE MINGEAU
58150
Trial participating centre
PHARMACIE BOUTINET-DJILANI
17650
Trial participating centre
PHARMACIE VITOUX-GILLET
59550
Trial participating centre
PHARMACIE MOUTIER-DUMAS
87130
Trial participating centre
PHARMACIE LEPINE
87220
Trial participating centre
PHARMACIE DRIOUT
41500
Trial participating centre
PHARMACIE TROUSSELLE
49000
Trial participating centre
PHARMACIE TARODO DE LA FUENTE
81240
Trial participating centre
PHARMACIE RAYMOND-TAUGOURDEAU
49112
Trial participating centre
PHARMACIE BEGLIA JOEL
13200
Trial participating centre
PHARMACIE SCHAUB
73230
Trial participating centre
PHARMACIE BREYSSE
81200
Trial participating centre
PHARMACIE MALLIS
62440
Trial participating centre
PHARMACIE BONCHRISTIANI-ANDREANI
13013
Trial participating centre
PHARMACIE BERGEZ-BEVALOT
25000
Trial participating centre
PHARMACIE RODIER CABANIS
30420
Trial participating centre
PHARMACIE DODIN-MOTTE
95290
Trial participating centre
PHARMACIE DECLOITRE
33000
Trial participating centre
PHARMACIE MILLERET-VERNAY
21250
Trial participating centre
PHARMACIE DOUCET
45260
Trial participating centre
PHARMACIE BEL
31340
Trial participating centre
PHARMACIE GIRARD-PLANTE-VIEITEZ
31660
Trial participating centre
PHARMACIE LHOYER
60160
Trial participating centre
PHARMACIE SENEZ VANGHELUE
60840
Trial participating centre
PHARMACIE COUFFIGNAL-BONNY
94370
Trial participating centre
PHARMACIE AATEF-VINAY
26000
Trial participating centre
PHARMACIE HENRY
18120
Trial participating centre
PHARMACIE EDUS
90170
Trial participating centre
PHARMACIE BIZON
49280
Trial participating centre
PHARMACIE CHARTIER SEBASTIEN
62660
Trial participating centre
PHARMACIE LECUGY-VINCENT
45420
Trial participating centre
PHARMACIE NOLL
67280
Trial participating centre
PHARMACIE BLAISE-GRASMICK
54220
Trial participating centre
PHARMACIE BERA
38114
Trial participating centre
PHARMACIE COGNARD-LOURADOUR
87920
Trial participating centre
PHARMACIE GUILLEBOT-VERGARA
31160
Trial participating centre
PHARMACIE DERAM
62220
Trial participating centre
PHARMACIE DESERICOURT-PEREZ
13100
Trial participating centre
PHARMACIE LOUBRIEU
49240
Trial participating centre
PHARMACIE KARAYAN
60700
Trial participating centre
PHARMACIE GUILLEBOT-VERGARA
31160
Trial participating centre
PHARMACIE DODIN-MOTTE
95290
Trial participating centre
PHARMACIE LE BAIL
95610
Trial participating centre
PHARMACIE GIANNECCHINI
13124
Trial participating centre
PHARMACIE VIVIEN-MINIGHETTI
13200
Trial participating centre
PHARMACIE BERA
38114
Trial participating centre
PHARMACIE MAGNIEN
21240
Trial participating centre
PHARMACIE FABERT
23350
Trial participating centre
PHARMACIE MAGNIEN
21140
Trial participating centre
PHARMACIE PENNE-LESPIAU
40230
Trial participating centre
PHARMACIE DERAM
62220
Trial participating centre
PHARMACIE VIVIEN-MINIGUETTI
13200
Trial participating centre
PHARMACIE HAMON-PALLU
56800
Trial participating centre
PHARMACIE OSTER-CHILD
67400
Trial participating centre
PHARMACIE LAFORTUNE
91390
Trial participating centre
PHARMACIE DESACHY-DAVERAT
40360
Trial participating centre
PHARMACIE TIVOLLIER-GOBILLOT
51000
Trial participating centre
PHARMACIE VIVIEN-MINIGHETTI
13200
Trial participating centre
PHARMACIE FACQ
60160
Trial participating centre
PHARMACIE MALLIS
62440
Trial participating centre
PHARMACIE BROUSSEAU
44100
Trial participating centre
PHARMACIE OSTER-HILD
67400
Trial participating centre
PHARMACIE GABRIELLNI-DURAND-BRESSAC
13012
Trial participating centre
PHARMACIE POTHELUNE
72190
Trial participating centre
PHARMACIE PERONNE-DETRIN
80000
Trial participating centre
PHARMACIE FRANCK
93220
Trial participating centre
PHARMACIE LEBAIL
95610
Trial participating centre
PHARMACIE AUCLAIRE
45390
Trial participating centre
PHARMACIE MATHEVET
85250
Trial participating centre
PHARMACIE TROUILLOT-MAURIN-FAURY-VAZQUEZ
33190
Trial participating centre
PHARMACIE MOUTIER-DUMAS
87130
Trial participating centre
PHARMACIE RETAILLEAU
85600
Trial participating centre
PHARMACIE LEFEBRVRE-RICQUEBOURG
95710
Trial participating centre
PHARMACIE POLETTI-REPELLIN
73200
Trial participating centre
PHARMACIE PERONNE-DETRIN
80000
Trial participating centre
PHARMACIE BONCHRISTIANI-ANDREANI
13013
Trial participating centre
PHARMACIE HAMON-PALLU
56800
Trial participating centre
PHARMACIE MEUNIER
42100
Trial participating centre
PHARMACIE PENICAUT-BECHADE
87800
Trial participating centre
PHARMACIE CAMY
34070
Trial participating centre
PHARMACIE LE BAIL
95610
Trial participating centre
PHARMACIE AGRA
49510
Trial participating centre
PHARMACIE SICARD
51000
Trial participating centre
PHARMACIE POTHELUNE
72190
Trial participating centre
PHARMACIE LECUGY-VINCENT
45420
Trial participating centre
PHARMACIE MIR-RABILLER
65170
Trial participating centre
PHARMACIE CHAU
92160
Trial participating centre
PHARMACIE MALLIS
62440
Trial participating centre
PHARMACIE CHIEP
91160
Trial participating centre
PHARMACIE LAIR-MARTIN-LONGUESSERRE
31260
Trial participating centre
PHARMACIE GIMENO-BUSSON
41210
Trial participating centre
PHARMACIE OSTER-HILD
67400
Trial participating centre
PHARMACIE DE GRAEVE-MASSIP
31600
Trial participating centre
PHARMACIE COUTINHO DE ALMEIDA
85000
Trial participating centre
PHARMACIE FAURY
17610
Trial participating centre
PHARMACIE BORDAT
84300
Trial participating centre
PHARMACIE LEPINE
87220
Trial participating centre
PHARMACIE ROUSSEAU
45250
Trial participating centre
PHARMACIE LAFFLY
1000
Trial participating centre
PHARMACIE CORGNE
81800
Trial participating centre
PHARMACIE COUTINHO DE ALMEIDA
85000
Trial participating centre
PHARMACIE STAHL
88290
Trial participating centre
PHARMACIE BAFFOUX - ROUET
86000
Trial participating centre
PHARMACIE LE BAIL
95610
Trial participating centre
PHARMACIE BOUCHARD
78610
Trial participating centre
PHARMACIE VAURY
91670
Trial participating centre
PHARMACIE BORDAT
84300
Trial participating centre
PHARMACIE MONTAGNY-WELLHOFF
92270
Trial participating centre
PHARMACIE VAURY
91670
Trial participating centre
PHARMACIE BAUDIN-CIMETIERE
71520
Trial participating centre
PHARMACIE LAFORTUNE
91390
Trial participating centre
PHARMACIE THOMAS
79380
Trial participating centre
PHARMACIE LEFEBVRE-RICQUEBOURG
95710
Trial participating centre
PHARMACIE SCHREVEL
94400
Trial participating centre
PHARMACIE GERMES - CANEPA
35300
Trial participating centre
PHARMACIE THOUVEREY
71500
Trial participating centre
PHARMACIE LOUBRIEU
49240
Trial participating centre
PHARMACIE OSTER-HILD
67400
Trial participating centre
PHARMACIE ENJALBERT - LAMASSIAUDE
82130
Trial participating centre
PHARMACIE LEFEBVRE-RICQUEBOURG
95710
Trial participating centre
PHARMACIE SAHUGUET
54110
Trial participating centre
PHARMACIE COGNARD - LOURADOUR
87920
Trial participating centre
PHARMACIE HENRY
18120
Trial participating centre
PHARMACIE HAMON - PALLU
56800
Trial participating centre
PHARMACIE SEGUIN
69290
Trial participating centre
PHARMACIE BONNIN - JOUANNIN
23320
Trial participating centre
PHARMACIE LAIR -MARTIN -LONGUESSERRE
31260
Trial participating centre
PHARMACIE SOL-GIRAL
43110
Trial participating centre
PHARMACIE DECLOITRE
3300
Trial participating centre
PHARMACIE COGNARD - LOURADOUR
87920
Trial participating centre
PHARMACIE BARBE - LECLERCQ
89110
Trial participating centre
PHARMACIE VIVIEN - MINIGHETTI
13200
Trial participating centre
PHARMACIE TIVOLLIER - GOBILLOT
51000
Trial participating centre
PHARMACIE LEYENDECKER
67130
Trial participating centre
PHARMACIE SEGUIN
69290
Trial participating centre
PHARMACIE BOUREL - EQUINET
80090
Trial participating centre
PHARMACIE DOUCET
45260
Trial participating centre
PHARMACIE LESOIF-GRIMAULT
53500
Trial participating centre
PHARMACIE BEGLIA JOEL
13200
Trial participating centre
PHARMACIE MOUSSLY
51230
Trial participating centre
PHARMACIE BOURDY-DUBOIS-CHANEL
58640
Trial participating centre
PHARMACIE VIVIEN - MINIGHETTI
13200
Trial participating centre
PHARMACIE HENRY
18120
Trial participating centre
PHARMACIE COHARD
86540
Trial participating centre
PHARMACIE LESOIF-GRIMAULT
53500
Sponsor information
Organisation
Observia
Sponsor details
Pépinière Paris Santé Cochin
29
Rue du Faubourg Saint Jacques
Paris
75014
France
+33 (0)1 81 80 24 50
laura.romengas@observia-group.com
Sponsor type
Research organisation
Website
Organisation
MSD France
Sponsor details
34 Avenue Léonard de Vinci
Courbevoie
92400
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Merck
Alternative name(s)
Merck & Co., Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact reviewed journal.
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Laura Romengas (laura.romengas@observia-group.com).
Intention to publish date
31/12/2017
Participant level data
Available on request
Results - basic reporting
Publication summary