Impact of a community pharmacy based information program on type 2 diabetic patients' adherence to their oral treatment

ISRCTN ISRCTN33776525
DOI https://doi.org/10.1186/ISRCTN33776525
Secondary identifying numbers 012014
Submission date
03/03/2017
Registration date
25/04/2017
Last edited
01/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Yves Michiels
Scientific

1 rue Guynemer
Longvic
21600
France

Study information

Study designProspective multicentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleImpact 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
Study acronymIPhODia
Study objectivesDiabetes 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(s)In France a clinical trial such as IPhODia does not require ethics approval
Health condition(s) or problem(s) studiedDiabetes
InterventionThe 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 typeOther
Primary outcome measureMedication 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 measures1. 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 study start date01/03/2014
Completion date31/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants800
Key inclusion criteria1. 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
Key exclusion criteria1. Cancer
2. Patients with insulin treatment or anti-diabetics injectables
Date of first enrolment01/03/2014
Date of final enrolment01/09/2016

Locations

Countries of recruitment

  • France

Study participating centres

PHARMACIE NGHIEM
91600
France
PHARMACIE BONNET
34000
France
PHARMACIE GOULET
76620
France
PHARMACIE SUEUR
80230
France
PHARMACIE HENRY
18120
France
PHARMACIE BOUDON
15120
France
PHARMACIE BERTHOLOM
29910
France
PHARMACIE LAIR-MARTIN-LONGUESSERRE
31260
France
PHARMACIE STAHL
88290
France
PHARMACIE BERTOUX-FORESTIER
80134
France
PHARMACIE BERA
38114
France
PHARMACIE DERAM
62220
France
PHARMACIE RENUCCI
84210
France
PHARMACIE SCHAUB
73230
France
PHARMACIE GERMES-CANEPA
35300
France
PHARMACIE LOUBRIEU
49240
France
PHARMACIE OSTER-HILD
67400
France
PHARMACIE LAFORTUNE
91390
France
PHARMACIE BIZON
49280
France
PHARMACIE VAURY
91670
France
PHARMACIE THOUVEREY
71500
France
PHARMACIE MINGEAU
58150
France
PHARMACIE BOUTINET-DJILANI
17650
France
PHARMACIE VITOUX-GILLET
59550
France
PHARMACIE MOUTIER-DUMAS
87130
France
PHARMACIE LEPINE
87220
France
PHARMACIE DRIOUT
41500
France
PHARMACIE TROUSSELLE
49000
France
PHARMACIE TARODO DE LA FUENTE
81240
France
PHARMACIE RAYMOND-TAUGOURDEAU
49112
France
PHARMACIE BEGLIA JOEL
13200
France
PHARMACIE SCHAUB
73230
France
PHARMACIE BREYSSE
81200
France
PHARMACIE MALLIS
62440
France
PHARMACIE BONCHRISTIANI-ANDREANI
13013
France
PHARMACIE BERGEZ-BEVALOT
25000
France
PHARMACIE RODIER CABANIS
30420
France
PHARMACIE DODIN-MOTTE
95290
France
PHARMACIE DECLOITRE
33000
France
PHARMACIE MILLERET-VERNAY
21250
France
PHARMACIE DOUCET
45260
France
PHARMACIE BEL
31340
France
PHARMACIE GIRARD-PLANTE-VIEITEZ
31660
France
PHARMACIE LHOYER
60160
France
PHARMACIE SENEZ VANGHELUE
60840
France
PHARMACIE COUFFIGNAL-BONNY
94370
France
PHARMACIE AATEF-VINAY
26000
France
PHARMACIE HENRY
18120
France
PHARMACIE EDUS
90170
France
PHARMACIE BIZON
49280
France
PHARMACIE CHARTIER SEBASTIEN
62660
France
PHARMACIE LECUGY-VINCENT
45420
France
PHARMACIE NOLL
67280
France
PHARMACIE BLAISE-GRASMICK
54220
France
PHARMACIE BERA
38114
France
PHARMACIE COGNARD-LOURADOUR
87920
France
PHARMACIE GUILLEBOT-VERGARA
31160
France
PHARMACIE DERAM
62220
France
PHARMACIE DESERICOURT-PEREZ
13100
France
PHARMACIE LOUBRIEU
49240
France
PHARMACIE KARAYAN
60700
France
PHARMACIE GUILLEBOT-VERGARA
31160
France
PHARMACIE DODIN-MOTTE
95290
France
PHARMACIE LE BAIL
95610
France
PHARMACIE GIANNECCHINI
13124
France
PHARMACIE VIVIEN-MINIGHETTI
13200
France
PHARMACIE BERA
38114
France
PHARMACIE MAGNIEN
21240
France
PHARMACIE FABERT
23350
France
PHARMACIE MAGNIEN
21140
France
PHARMACIE PENNE-LESPIAU
40230
France
PHARMACIE DERAM
62220
France
PHARMACIE VIVIEN-MINIGUETTI
13200
France
PHARMACIE HAMON-PALLU
56800
France
PHARMACIE OSTER-CHILD
67400
France
PHARMACIE LAFORTUNE
91390
France
PHARMACIE DESACHY-DAVERAT
40360
France
PHARMACIE TIVOLLIER-GOBILLOT
51000
France
PHARMACIE VIVIEN-MINIGHETTI
13200
France
PHARMACIE FACQ
60160
France
PHARMACIE MALLIS
62440
France
PHARMACIE BROUSSEAU
44100
France
PHARMACIE OSTER-HILD
67400
France
PHARMACIE GABRIELLNI-DURAND-BRESSAC
13012
France
PHARMACIE POTHELUNE
72190
France
PHARMACIE PERONNE-DETRIN
80000
France
PHARMACIE FRANCK
93220
France
PHARMACIE LEBAIL
95610
France
PHARMACIE AUCLAIRE
45390
France
PHARMACIE MATHEVET
85250
France
PHARMACIE TROUILLOT-MAURIN-FAURY-VAZQUEZ
33190
France
PHARMACIE MOUTIER-DUMAS
87130
France
PHARMACIE RETAILLEAU
85600
France
PHARMACIE LEFEBRVRE-RICQUEBOURG
95710
France
PHARMACIE POLETTI-REPELLIN
73200
France
PHARMACIE PERONNE-DETRIN
80000
France
PHARMACIE BONCHRISTIANI-ANDREANI
13013
France
PHARMACIE HAMON-PALLU
56800
France
PHARMACIE MEUNIER
42100
France
PHARMACIE PENICAUT-BECHADE
87800
France
PHARMACIE CAMY
34070
France
PHARMACIE LE BAIL
95610
France
PHARMACIE AGRA
49510
France
PHARMACIE SICARD
51000
France
PHARMACIE POTHELUNE
72190
France
PHARMACIE LECUGY-VINCENT
45420
France
PHARMACIE MIR-RABILLER
65170
France
PHARMACIE CHAU
92160
France
PHARMACIE MALLIS
62440
France
PHARMACIE CHIEP
91160
France
PHARMACIE LAIR-MARTIN-LONGUESSERRE
31260
France
PHARMACIE GIMENO-BUSSON
41210
France
PHARMACIE OSTER-HILD
67400
France
PHARMACIE DE GRAEVE-MASSIP
31600
France
PHARMACIE COUTINHO DE ALMEIDA
85000
France
PHARMACIE FAURY
17610
France
PHARMACIE BORDAT
84300
France
PHARMACIE LEPINE
87220
France
PHARMACIE ROUSSEAU
45250
France
PHARMACIE LAFFLY
1000
France
PHARMACIE CORGNE
81800
France
PHARMACIE COUTINHO DE ALMEIDA
85000
France
PHARMACIE STAHL
88290
France
PHARMACIE BAFFOUX - ROUET
86000
France
PHARMACIE LE BAIL
95610
France
PHARMACIE BOUCHARD
78610
France
PHARMACIE VAURY
91670
France
PHARMACIE BORDAT
84300
France
PHARMACIE MONTAGNY-WELLHOFF
92270
France
PHARMACIE VAURY
91670
France
PHARMACIE BAUDIN-CIMETIERE
71520
France
PHARMACIE LAFORTUNE
91390
France
PHARMACIE THOMAS
79380
France
PHARMACIE LEFEBVRE-RICQUEBOURG
95710
France
PHARMACIE SCHREVEL
94400
France
PHARMACIE GERMES - CANEPA
35300
France
PHARMACIE THOUVEREY
71500
France
PHARMACIE LOUBRIEU
49240
France
PHARMACIE OSTER-HILD
67400
France
PHARMACIE ENJALBERT - LAMASSIAUDE
82130
France
PHARMACIE LEFEBVRE-RICQUEBOURG
95710
France
PHARMACIE SAHUGUET
54110
France
PHARMACIE COGNARD - LOURADOUR
87920
France
PHARMACIE HENRY
18120
France
PHARMACIE HAMON - PALLU
56800
France
PHARMACIE SEGUIN
69290
France
PHARMACIE BONNIN - JOUANNIN
23320
France
PHARMACIE LAIR -MARTIN -LONGUESSERRE
31260
France
PHARMACIE SOL-GIRAL
43110
France
PHARMACIE DECLOITRE
3300
France
PHARMACIE COGNARD - LOURADOUR
87920
France
PHARMACIE BARBE - LECLERCQ
89110
France
PHARMACIE VIVIEN - MINIGHETTI
13200
France
PHARMACIE TIVOLLIER - GOBILLOT
51000
France
PHARMACIE LEYENDECKER
67130
France
PHARMACIE SEGUIN
69290
France
PHARMACIE BOUREL - EQUINET
80090
France
PHARMACIE DOUCET
45260
France
PHARMACIE LESOIF-GRIMAULT
53500
France
PHARMACIE BEGLIA JOEL
13200
France
PHARMACIE MOUSSLY
51230
France
PHARMACIE BOURDY-DUBOIS-CHANEL
58640
France
PHARMACIE VIVIEN - MINIGHETTI
13200
France
PHARMACIE HENRY
18120
France
PHARMACIE COHARD
86540
France
PHARMACIE LESOIF-GRIMAULT
53500
France

Sponsor information

Observia
Research organisation

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
MSD France
Industry

34 Avenue Léonard de Vinci
Courbevoie
92400
France

Funders

Funder type

Industry

Merck
Government organisation / For-profit companies (industry)
Alternative name(s)
Merck & Co., Inc., Merck & Co.
Location
United States of America

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Laura Romengas (laura.romengas@observia-group.com).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2019 01/05/2020 Yes No

Editorial Notes

01/05/2020: Publication reference added.

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