Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Conditions
Keywords
Medication adherence, Diabetes Mellitus, Renal Insufficiency, Chronic, Interprofessional Relations
Brief summary
Monocentric, randomised, controlled and open study. Subjects will be included prospectively and consecutively and randomly assigned into two groups. Intervention group A will benefit a medication adherence support program during 12 months while intervention group B during 6 months only. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visit, the pharmacist will conduct a semi-structured interview in 15 minutes based on Fisher's sociocognitive model with the patients. A summary of the interview and the adherence graph will be send to the patient' health professionals.
Detailed description
In addition to usual care, patients are included in a medication adherence support program combining an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd) and motivational semi-structured interviews. This programm is held by the Unisanté's community pharmacists\*, in coordination with medical and nurse staff , to support medication adherence and to promote the continuity of care. For patients not speaking french, english, or italian, the interviews will be done with a interpreter. The medication adherence data will be analysed in both groups along with clinical data obtained through draw samples regularly prescribed by the physician. \*Since the 1st January 2019, the Policlinique Médicale Universitaire became Unisanté, University Center for Primary Care and Public Health (Lausanne, Switzerland).
Interventions
OTHERInteprofessional medication adherence support program (IMAP)
In addition to usual care, patients participate in a medication adherence support program combining an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd) and motivational semi-structured interviews. This programm is done by the Unisanté's community pharmacists, in coordination with medical and nurse staff , to support medication adherence and to promote continuity of care. The intervention is held at the Unisanté's community pharmacy. For patients not speaking french, english, or italien, the interviews will be done with a interpreter.
Sponsors
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
pharmaSuisse
santésuisse
Curafutura
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* MDRD or CKD-EPI eGFR ≤60 ml/min/1.73m2 or albumin/creatinin \>30mg/mmol * Type 2 diabetes * At least one medication in the following list : oral antidiabetics and/or statins and/or antihypertensive drugs and/or aspirin * Patients speaking french, english or italian or interpreter present at each pharmacy visit * Patients have to sign the written consent form * Patients have to agree to use the Electronic Monitoring system (EM, named MEMS®; Aardex Ltd) * Complete laboratory exams in the last 6 months: eGFR and HbA1c and (albumin/creatinin ratio or total cholesterol + LDL + HDL)
Exclusion criteria
* Not being able to understand or sign the consent form * Pregnancy * Recent cancer diagnosis * Cognitive disorder * The subject does not manage the treatment alone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence (longitudinal data) | 24 months | Implementation and persistance during the intervention phase (6 or 12 months) and during the post-intervention phase (18 months or 12 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | Baseline, 6 monts and 12 months post-intervention | ADVANCE kidney score |
| Medication adherence | 6 months or 12 months post-intervention phase | Number of patients with an electronic medication adherence ≤ 30% for at least one medication throughout two successive pharmacy visits during the post-intervention phase |
| Patients' satisfaction | At 6 months or 12 months (end of the intervention phase) or at the stop of the study (24 months if the patient ends the study or between the end of the intervention phase (6 months or 12 months) and 24 months. | In depths and semi-structured interviews to assess patient's opinions about the program |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORMarie-Paule Schneider, Prof.
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
PRINCIPAL_INVESTIGATORCarole Bandiera, PhD student
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
PRINCIPAL_INVESTIGATORAnne Zanchi, PhD-PD
CHUV (Centre hospitalier Universitaire Vaudois)
Outcome results
None listed