Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/03/2017
Date assigned
25/04/2017
Last edited
01/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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

Contact information

Type

Scientific

Primary contact

Dr Yves Michiels

ORCID ID

Contact details

1 rue Guynemer
Longvic
21600
France

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 measure

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 (if study stopped)

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
France

Trial participating centre

PHARMACIE BONNET
34000
France

Trial participating centre

PHARMACIE GOULET
76620
France

Trial participating centre

PHARMACIE SUEUR
80230
France

Trial participating centre

PHARMACIE HENRY
18120
France

Trial participating centre

PHARMACIE BOUDON
15120
France

Trial participating centre

PHARMACIE BERTHOLOM
29910
France

Trial participating centre

PHARMACIE LAIR-MARTIN-LONGUESSERRE
31260
France

Trial participating centre

PHARMACIE STAHL
88290
France

Trial participating centre

PHARMACIE BERTOUX-FORESTIER
80134
France

Trial participating centre

PHARMACIE BERA
38114
France

Trial participating centre

PHARMACIE DERAM
62220
France

Trial participating centre

PHARMACIE RENUCCI
84210
France

Trial participating centre

PHARMACIE SCHAUB
73230
France

Trial participating centre

PHARMACIE GERMES-CANEPA
35300
France

Trial participating centre

PHARMACIE LOUBRIEU
49240
France

Trial participating centre

PHARMACIE OSTER-HILD
67400
France

Trial participating centre

PHARMACIE LAFORTUNE
91390
France

Trial participating centre

PHARMACIE BIZON
49280
France

Trial participating centre

PHARMACIE VAURY
91670
France

Trial participating centre

PHARMACIE THOUVEREY
71500
France

Trial participating centre

PHARMACIE MINGEAU
58150
France

Trial participating centre

PHARMACIE BOUTINET-DJILANI
17650
France

Trial participating centre

PHARMACIE VITOUX-GILLET
59550
France

Trial participating centre

PHARMACIE MOUTIER-DUMAS
87130
France

Trial participating centre

PHARMACIE LEPINE
87220
France

Trial participating centre

PHARMACIE DRIOUT
41500
France

Trial participating centre

PHARMACIE TROUSSELLE
49000
France

Trial participating centre

PHARMACIE TARODO DE LA FUENTE
81240
France

Trial participating centre

PHARMACIE RAYMOND-TAUGOURDEAU
49112
France

Trial participating centre

PHARMACIE BEGLIA JOEL
13200
France

Trial participating centre

PHARMACIE SCHAUB
73230
France

Trial participating centre

PHARMACIE BREYSSE
81200
France

Trial participating centre

PHARMACIE MALLIS
62440
France

Trial participating centre

PHARMACIE BONCHRISTIANI-ANDREANI
13013
France

Trial participating centre

PHARMACIE BERGEZ-BEVALOT
25000
France

Trial participating centre

PHARMACIE RODIER CABANIS
30420
France

Trial participating centre

PHARMACIE DODIN-MOTTE
95290
France

Trial participating centre

PHARMACIE DECLOITRE
33000
France

Trial participating centre

PHARMACIE MILLERET-VERNAY
21250
France

Trial participating centre

PHARMACIE DOUCET
45260
France

Trial participating centre

PHARMACIE BEL
31340
France

Trial participating centre

PHARMACIE GIRARD-PLANTE-VIEITEZ
31660
France

Trial participating centre

PHARMACIE LHOYER
60160
France

Trial participating centre

PHARMACIE SENEZ VANGHELUE
60840
France

Trial participating centre

PHARMACIE COUFFIGNAL-BONNY
94370
France

Trial participating centre

PHARMACIE AATEF-VINAY
26000
France

Trial participating centre

PHARMACIE HENRY
18120
France

Trial participating centre

PHARMACIE EDUS
90170
France

Trial participating centre

PHARMACIE BIZON
49280
France

Trial participating centre

PHARMACIE CHARTIER SEBASTIEN
62660
France

Trial participating centre

PHARMACIE LECUGY-VINCENT
45420
France

Trial participating centre

PHARMACIE NOLL
67280
France

Trial participating centre

PHARMACIE BLAISE-GRASMICK
54220
France

Trial participating centre

PHARMACIE BERA
38114
France

Trial participating centre

PHARMACIE COGNARD-LOURADOUR
87920
France

Trial participating centre

PHARMACIE GUILLEBOT-VERGARA
31160
France

Trial participating centre

PHARMACIE DERAM
62220
France

Trial participating centre

PHARMACIE DESERICOURT-PEREZ
13100
France

Trial participating centre

PHARMACIE LOUBRIEU
49240
France

Trial participating centre

PHARMACIE KARAYAN
60700
France

Trial participating centre

PHARMACIE GUILLEBOT-VERGARA
31160
France

Trial participating centre

PHARMACIE DODIN-MOTTE
95290
France

Trial participating centre

PHARMACIE LE BAIL
95610
France

Trial participating centre

PHARMACIE GIANNECCHINI
13124
France

Trial participating centre

PHARMACIE VIVIEN-MINIGHETTI
13200
France

Trial participating centre

PHARMACIE BERA
38114
France

Trial participating centre

PHARMACIE MAGNIEN
21240
France

Trial participating centre

PHARMACIE FABERT
23350
France

Trial participating centre

PHARMACIE MAGNIEN
21140
France

Trial participating centre

PHARMACIE PENNE-LESPIAU
40230
France

Trial participating centre

PHARMACIE DERAM
62220
France

Trial participating centre

PHARMACIE VIVIEN-MINIGUETTI
13200
France

Trial participating centre

PHARMACIE HAMON-PALLU
56800
France

Trial participating centre

PHARMACIE OSTER-CHILD
67400
France

Trial participating centre

PHARMACIE LAFORTUNE
91390
France

Trial participating centre

PHARMACIE DESACHY-DAVERAT
40360
France

Trial participating centre

PHARMACIE TIVOLLIER-GOBILLOT
51000
France

Trial participating centre

PHARMACIE VIVIEN-MINIGHETTI
13200
France

Trial participating centre

PHARMACIE FACQ
60160
France

Trial participating centre

PHARMACIE MALLIS
62440
France

Trial participating centre

PHARMACIE BROUSSEAU
44100
France

Trial participating centre

PHARMACIE OSTER-HILD
67400
France

Trial participating centre

PHARMACIE GABRIELLNI-DURAND-BRESSAC
13012
France

Trial participating centre

PHARMACIE POTHELUNE
72190
France

Trial participating centre

PHARMACIE PERONNE-DETRIN
80000
France

Trial participating centre

PHARMACIE FRANCK
93220
France

Trial participating centre

PHARMACIE LEBAIL
95610
France

Trial participating centre

PHARMACIE AUCLAIRE
45390
France

Trial participating centre

PHARMACIE MATHEVET
85250
France

Trial participating centre

PHARMACIE TROUILLOT-MAURIN-FAURY-VAZQUEZ
33190
France

Trial participating centre

PHARMACIE MOUTIER-DUMAS
87130
France

Trial participating centre

PHARMACIE RETAILLEAU
85600
France

Trial participating centre

PHARMACIE LEFEBRVRE-RICQUEBOURG
95710
France

Trial participating centre

PHARMACIE POLETTI-REPELLIN
73200
France

Trial participating centre

PHARMACIE PERONNE-DETRIN
80000
France

Trial participating centre

PHARMACIE BONCHRISTIANI-ANDREANI
13013
France

Trial participating centre

PHARMACIE HAMON-PALLU
56800
France

Trial participating centre

PHARMACIE MEUNIER
42100
France

Trial participating centre

PHARMACIE PENICAUT-BECHADE
87800
France

Trial participating centre

PHARMACIE CAMY
34070
France

Trial participating centre

PHARMACIE LE BAIL
95610
France

Trial participating centre

PHARMACIE AGRA
49510
France

Trial participating centre

PHARMACIE SICARD
51000
France

Trial participating centre

PHARMACIE POTHELUNE
72190
France

Trial participating centre

PHARMACIE LECUGY-VINCENT
45420
France

Trial participating centre

PHARMACIE MIR-RABILLER
65170
France

Trial participating centre

PHARMACIE CHAU
92160
France

Trial participating centre

PHARMACIE MALLIS
62440
France

Trial participating centre

PHARMACIE CHIEP
91160
France

Trial participating centre

PHARMACIE LAIR-MARTIN-LONGUESSERRE
31260
France

Trial participating centre

PHARMACIE GIMENO-BUSSON
41210
France

Trial participating centre

PHARMACIE OSTER-HILD
67400
France

Trial participating centre

PHARMACIE DE GRAEVE-MASSIP
31600
France

Trial participating centre

PHARMACIE COUTINHO DE ALMEIDA
85000
France

Trial participating centre

PHARMACIE FAURY
17610
France

Trial participating centre

PHARMACIE BORDAT
84300
France

Trial participating centre

PHARMACIE LEPINE
87220
France

Trial participating centre

PHARMACIE ROUSSEAU
45250
France

Trial participating centre

PHARMACIE LAFFLY
1000
France

Trial participating centre

PHARMACIE CORGNE
81800
France

Trial participating centre

PHARMACIE COUTINHO DE ALMEIDA
85000
France

Trial participating centre

PHARMACIE STAHL
88290
France

Trial participating centre

PHARMACIE BAFFOUX - ROUET
86000
France

Trial participating centre

PHARMACIE LE BAIL
95610
France

Trial participating centre

PHARMACIE BOUCHARD
78610
France

Trial participating centre

PHARMACIE VAURY
91670
France

Trial participating centre

PHARMACIE BORDAT
84300
France

Trial participating centre

PHARMACIE MONTAGNY-WELLHOFF
92270
France

Trial participating centre

PHARMACIE VAURY
91670
France

Trial participating centre

PHARMACIE BAUDIN-CIMETIERE
71520
France

Trial participating centre

PHARMACIE LAFORTUNE
91390
France

Trial participating centre

PHARMACIE THOMAS
79380
France

Trial participating centre

PHARMACIE LEFEBVRE-RICQUEBOURG
95710
France

Trial participating centre

PHARMACIE SCHREVEL
94400
France

Trial participating centre

PHARMACIE GERMES - CANEPA
35300
France

Trial participating centre

PHARMACIE THOUVEREY
71500
France

Trial participating centre

PHARMACIE LOUBRIEU
49240
France

Trial participating centre

PHARMACIE OSTER-HILD
67400
France

Trial participating centre

PHARMACIE ENJALBERT - LAMASSIAUDE
82130
France

Trial participating centre

PHARMACIE LEFEBVRE-RICQUEBOURG
95710
France

Trial participating centre

PHARMACIE SAHUGUET
54110
France

Trial participating centre

PHARMACIE COGNARD - LOURADOUR
87920
France

Trial participating centre

PHARMACIE HENRY
18120
France

Trial participating centre

PHARMACIE HAMON - PALLU
56800
France

Trial participating centre

PHARMACIE SEGUIN
69290
France

Trial participating centre

PHARMACIE BONNIN - JOUANNIN
23320
France

Trial participating centre

PHARMACIE LAIR -MARTIN -LONGUESSERRE
31260
France

Trial participating centre

PHARMACIE SOL-GIRAL
43110
France

Trial participating centre

PHARMACIE DECLOITRE
3300
France

Trial participating centre

PHARMACIE COGNARD - LOURADOUR
87920
France

Trial participating centre

PHARMACIE BARBE - LECLERCQ
89110
France

Trial participating centre

PHARMACIE VIVIEN - MINIGHETTI
13200
France

Trial participating centre

PHARMACIE TIVOLLIER - GOBILLOT
51000
France

Trial participating centre

PHARMACIE LEYENDECKER
67130
France

Trial participating centre

PHARMACIE SEGUIN
69290
France

Trial participating centre

PHARMACIE BOUREL - EQUINET
80090
France

Trial participating centre

PHARMACIE DOUCET
45260
France

Trial participating centre

PHARMACIE LESOIF-GRIMAULT
53500
France

Trial participating centre

PHARMACIE BEGLIA JOEL
13200
France

Trial participating centre

PHARMACIE MOUSSLY
51230
France

Trial participating centre

PHARMACIE BOURDY-DUBOIS-CHANEL
58640
France

Trial participating centre

PHARMACIE VIVIEN - MINIGHETTI
13200
France

Trial participating centre

PHARMACIE HENRY
18120
France

Trial participating centre

PHARMACIE COHARD
86540
France

Trial participating centre

PHARMACIE LESOIF-GRIMAULT
53500
France

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., Merck & Co., Merck & Co Inc

Funding Body Type

government organisation

Funding Body Subtype

For-profit companies (industry)

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

Basic results (scientific)

Publication list

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31049873 (added 01/05/2020)

Publication citations

Additional files

Editorial Notes

01/05/2020: Publication reference added.