ELECTRONIC MONITORS IN PATIENTS WITH CARDIOVASCULAR MEDICATION: A PILOT STUDY IN PRIMARY CARE

Transcription

1 INTERVENTION EFFECT OF ELECTRONIC MONITORS IN PATIENTS WITH CARDIOVASCULAR MEDICATION: A PILOT STUDY IN PRIMARY CARE Andreas Zeller University Hospital Basel & Esther Ramseier Family Practice Oberwil

2 Introduction Hypertension, type 2 diabetes, and dyslipidemia are common conditions in primary health care To control asymptomatic conditions is notoriously difficult Wolf-Meier K, JAMA 2003;289:

3 Why? Asymptomatic pts might forget to take medication Asymptomatic pts might feel worse due to side effects Adherence/persistence even more difficult and possibly not adequate

4 Adherence to long-term therapies e.g. Diabetes e.g. Hypertension Dailey J. Clin Therap 2001;23: Vrijens B. BMJ 2008;376:

5 Electronic Monitoring (EM) Assessment of adherence = crucial first step to improve adherence Electronic monitors = helpful, sensitive, and reliable Adherence assessment AND intervention? Does this potential intervention effect of EM wane over time?

6 EM: Adherence assessment AND intervention? Author Year Design Sample n Observation Result Wagner et al. Wetzels et al. Santschi et al. Burnier et al. Bertholet et al RCT HAART weeks 2007 RCT 2008 Cluster RCT Pre/post intervention Pre/post intervention Blood pressure control Blood pressure control Therapy resistant hypertension months months months Blood pressure months EM (91%) vs. control (94%), p=0.73 EM (51%) vs. control (54%), p=0.73 BP control improved after 4 months (p<0.05), but n.s. after 12 months BP improved after EM (-12/9mmHg) BP inproved after EM (-14/9mmHg)

7 Waning intervention effect of EM Author Year Sample n Observation Result Dechamps et al. Denhaerynck et al HAART months at least 40 days 2008 Kidney transplants months ~ 35 days

8 Objective To evaluate the potential adherence-enhancing effect of EM in patients being treated for hypertension, type 2 diabetes, or dyslipidemia in a primary care setting (pilot project)

9 Methods I Design: Setting: Participants: - Prospective observational - Medical Outpatient Department, single centre - At least one medication for the respective condition Inclusion criteria: Individuals (>18 years of age) with a clinical diagnosis of essential hypertension, or type 2 diabetes, or dyslipidaemia Exclusion criteria: Dementia, secondary hypertension, use of a dose organizer ( dosette box )

10 Methods II Eligible patients Allocation (random number tables), 2:1 Group 1: Info MEMS Yes Group 2: Info MEMS No Approach during a routine consultation Would you basically use this pillbox as a drug dispender for the subsequent 10 weeks? Informed consent & collection baseline characteristics Approved by the ethical committee

11 Methods III Group 1 : received detailed information on the EM: you will be given this special pill container for one of your tablets ( ), which has an electronic watch in its screw-top closure Every opening will be recorded (date and time) by the chip in the lid. Your medication taking will therefore taking be monitored continuously The information collected by the microchip will be downloaded to a computer and your individual medication taking pattern will be analysed. You will get this information leaflet summarising how to use the EM. Please read carefully before using the electronic pillbox.

12 Information leaflet on the electronic monitor Communicator (MEMS 6) 2. Pill Container 3. USB connector to laptop / PC 4. Lid containing the microchip 4 3 How to use the special tablet container In order to learn more about dosing patterns in people who are prescribed blood pressure lowering tablets, we are providing you with a special tablet container (MEMS container). This tablet container has an electronic watch in its screw-top closure. Thus we can register the date and time you open the bottle to take your tablets. When using the MEMS -container, please pay attention to the following: You have been prescribed. Whenever you get a new prescription for these tablets, please take them out of the original packet and transfer them into the MEMS -container (preferably at the time when you would take a dose out anyway) Take only out of this MEMS - container. Open the MEMS -container only when you intend to take a tablet of. Close the MEMS -container promptly after removing a tablet of. Never leave the MEMS -container open. If for any reason there is a change in the pattern of your pill-taking (for example, due to a holiday, moving house, sudden illness etc.) we would be grateful if you could make a note in a little note book or on a sheet of paper and bring it with you to the next appointment with Dr Andy Zeller Please take your MEMS -container with you whenever you see the nurse or Dr Andy Zeller at the surgery and return it at the end of the study. Contact details of Dr Andy Zeller and Dr Esther Ramseier on the back Thank you very much!

13 Methods IV Group 2 : received NO further information on the EM: We d like to test a technology that records when you open the lid. We d like to ask you to fill the container with a 10 week supply of.... and use the device as a drug dispenser. Patient did NOT receive an information leaflet

14 Results I: Study sample Eligible patients n =125 n = 29 not interested (21) reject MEMS (8) n = 7 not used EM (5) not returned (1) died (1) Info MEMS Yes (Group 1) n = 85 included n = 56 MEMS data n = 49 Info MEMS No (Group 2) n = 40 included n = 22 MEMS data n= 17 n = 18 not interested (10) Requested more information on MEMS! (8) n = 5 not used (4) Not returned

15 Results II: Study sample Characteristic Description Mean age (years) ± SD 61.9 ± 12.5 Gender male, n (%) 46 (58.9) Mean body mass index (kg/m 2 ) ± SD 28.9 ± 5.4 Non-smokers, n (%) 60 (76.9) Adherence monitored on 75 ± 12 days

16 Results III MEMS measured Adherence in Hypertensive, Diabetic, and Dyslipidemic Patients Hypertension Diabetes Dyslipidaemia (n = 27) (n = 17) (n = 22) p value* Timing adherence, % Correct dosing, % Taking adherence, % 72 ± ± ± ± ± ± ± ± ± *one-way analysis of variance (ANOVA)

17 Results IV p=0.10 p=0.035 p=0.64 % (MEMS) Adherence % Info MEMS Yes Info MEMS No 0 Timing adherene Correct dosing Taking adherence

18 Limitations Small study sample (n = 66), pilot project Exclusion of 8 (20%) in Group Info NO Values are means over the whole obervation period No information on a possible waning effect

19 Conclusions Trend towards better adherence rates in the informed group compared to the uninformed group. A potential adherence-enhancing effect of EM cannot be excluded during an observation period of 10 weeks. No difference in adherence rates between patients with hypertension, type 2 diabetes, or dyslipidaemia. Remaining problem of how to NOT inform participants on the functioning of EM.

20 Thank you for your attention!

21 Outlook Our pilot study may justify a following evaluation in a larger population to further determine the effect of EMs on medication taking behaviour. Further analyses of the present data to elucidate whether Further analyses of the present data to elucidate whether the possible intervention effect wanes over time.