Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/03/2017
Date assigned
25/04/2017
Last edited
20/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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

Publication citations

Additional files

Editorial Notes