DESIGN: Randomized clinical trial with parallel-group design guided by the CONSORT checklist.
METHODS: In this study, sixty cardiovascular inpatients were selected through convenience sampling and then randomly assigned to control and intervention groups, in 2018, Iran. The intervention group took responsibility for consuming their prescribed medication according to the self-administration of medication programme and the control group took medications routinely. Medication adherence was measured one and two weeks after the discharge via telephonic follow-up by Morisky Medication Adherence Scale MMAS-8-item and nurses' satisfaction by researcher-made questioner.
RESULT: There was a higher medication adherence level in the intervention group rather than the usual care group at the follow-up. Most nurses in the study environment were very satisfied.
CONCLUSION: The self-administration of medication programme can effectively increase patients' medication adherence and nurses' satisfaction.
METHODS/DESIGN: This is a prospective, parallel-design, two-treatment-group randomized controlled trial to evaluate the effectiveness and sustainability of MEDIHEALTH in improving medication adherence. Malay patients who have underlying T2DM, who obtain medication therapy at Petra Jaya Health Clinic and Kota Samarahan Health Clinic, and who have a moderate to low adherence level (8-item Morisky Medication Adherence Scale, Malaysian specific, score <6) were randomly assigned to the treatment group (MEDIHEALTH) or the control group. The primary outcome of this study is medication adherence level at baseline and 1, 3, 6 and 12 months post-intervention. The secondary outcomes are attitude, subjective norms, perceived behavioural control, intention and knowledge related to medication adherence measured at baseline and 1, 6 and 12 months post-intervention. The effectiveness and sustainability of the Program will be triangulated by findings from semi-structured interviews with five selected participants conducted 1 month after the intervention and in-depth interviews with two main facilitators and two managerial officers in charge of the Program 12 months after the intervention. Statistical analyses of quantitative data were conducted using SPSS version 22 and Stata version 14. Thematic analysis for qualitative data were conducted with the assistance of ATLAS.ti 8.
DISCUSSION: This study provides evidence on the effectiveness and sustainability of a structured group-based educational program that employs multiple theoretical grounding and a culturally sensitive approach in promoting medication adherence among Malays with underlying T2DM. Both the quantitative and qualitative findings of this study could assist in the future development of the Program.
TRIAL REGISTRATION: National Medical Research Register, NMRR-17-925-35875 (IIR). Registered on 19 May 2017. ClinicalTrials.gov, NCT03228706 . Registered on 25 July 2017.