IMPROVING DIABETIC PATIENTS’ ADHERENCE TO TREATMENT PROGRAM BY USING COMMUNITY BASED INTERACTIVE APPROACH-DIABETES MELLITUS (CBIA-DM) STRATEGY IN HOSPITAL BASED PATIENTS COMMUNITY Titien Siwi Hartayu1 & 2, Aji Rustamaji2, Nurita Prasidayani2, Sri Suryawati2 1Faculty of Pharmacy Sanata Dharma University, Indonesia PhD candidate in Discipline of Social and Administrative Pharmacy Universiti Sains Malaysia 2 Centre for Clinical Pharmacology and Medicine Policy Studies Gadjah Mada University, Indonesia.

Abstract IMPROVING DIABETIC PATIENTS’ ADHERENCE TO TREATMENT PROGRAM BY USING COMMUNITY BASED INTERACTIVE APPROACH-DIABETES MELLITUS (CBIA-DM) STRATEGY IN HOSPITAL- BASED PATIENTS COMMUNITY Titien Siwi Hartayu1 & 2, Aji Rustamaji2, Nurita Prasidayani2, Sri Suryawati2 1Faculty of Pharmacy Sanata Dharma University, Indonesia PhD candidate in Discipline of Social and Administrative Pharmacy Universiti Sains Malaysia 2 Centre for Clinical Pharmacology and Medicine Policy Studies Gadjah Mada University, Indonesia. Problem Statement: As a chronic disease, diabetes-mellitus is a high risk in complications. In order to reduce diabetes-related complications, adherence to treatment program is necessary. Unfortunately, adherence to treatment program of diabetic patients remains problematic. Therefore, developed a strategy to improve diabetic patients’ adherence to treatment program by adapting the CBIA (Mothers’ Active Learning Method) is needed. The new strategy is called CBIA-DM. Objectives: To evaluate the impact of CBIA-DM strategy on diabetic patients’ knowledge, attitude, practice and adherence to treatment program. Design: Intervention study, utilizing time series, pre and post quasi-experimental with control group study design. Setting: The study was conducted in two charity hospitals in Yogyakarta, i.e.: Panti Rapih and Panti Rini hospitals. Panti Rapih DM club was selected as intervention site and Panti Rini DM club was chosen as control site. Study Population: Members of DM club, and/or their caregiver of Panti Rapih and Panti Rini hospitals. Intervention: Small group discussion interactive approach in one session program with two hours duration of activities. The activities covered introduction, active self-learning using CBIA-DM package, and wrap up and conclusion by DM experts. Data were collected at pre intervention, immediately, 2 weeks and 4 weeks post intervention. Adherence to treatment program was assessed by calculating the number of remaining tablets on the day pre test and post test, recording patients’ recall in diet, exercise and foot care practices per day and per week by nurses. Effectiveness of this hospital-based patient community program in charity hospital setting was assessed based on the increasing of knowledge, attitude, practice, adherence, intervention cost and acceptance of CBIA-DM by providers and participants; using Wilcoxon test, p < 0.005. Policy: CBIA-DM strategy can be used as patients’ empowerment in hospital setting. Outcome Measures: Knowledge, practice and adherence to treatment program, cost of intervention and acceptance of CBIA-DM program by the head of diabetic club and participants Results: CBIA-DM group significantly improved the knowledge score from 7.7 to 8.6 (p < 0.005) and practice from 4.6 to 6.0 (p < 0.005) with score range 0-11, but not for the atttude score. Adherence increased from 30% vs. 16.7% at baseline, up to 46.7% vs. 23.3% at post 1 and 30% vs. 13.3% at post 2. CBIA-DM program was conducted in two hours with unit cost US$ 4.00 per person cheaper than regular seminar in DM Club (US$ 8.00). Participants and provider expressed that CBIA-DM was easy to be followed and enjoyable. Conclusions: CBIA-DM package improved patients’ knowledge, practice and adherence to diabetes self-care. It is an effective strategy which is easy to be followed and enjoyable. It is also feasible to be implemented in hospital-based setting as medium for RUM (Rational Use of Medicines) education. However, improvement of the program is still needed to sustain the impact of the program. Keywords: CBIA-DM, Diabetes Mellitus, Adherence, Hospital-based patients community, DM club.

BACKGROUND Prevalence of type 2 diabetes increases globally*. 70% of diabetic patients lives in developing countries (Indonesia is the fourth rank) and is estimated to be the fifth leading cause of death** Promotion of healthy life style is the most important factors in the health care management*** Physicians’ time for consultation is very limited Solution to accommodate diabetic patients’ information needs regarding their disease is needed Non-adherence to treatment program is still as the main problem in diabetic patients****. Special effort to improve the adherence to treatment program for people with diabetes mellitus is urgently needed ____________________________________________________________________________ * Sutanegara, D., Budiarta, (2000) The epidemiology and management of diabetes mellitus in Indonesia [online]. [Accessed at 29th October 2005]. Available from World wide web:http://www:ncbi.nlm.nih.gov/entrez/query.fcgl?cdm=retrieve&db ** Robles, YHK., Edwards AGK., Cannings-John, R., Butler, C.,(2007) Health education for diabetes mellitus type 2 in ethnic minority groups (protocol). The Cochrane Library, 2, p.1-16 *** Ghazanfari, Z., Ghofranipour , F., Tavafian SS., Ahmadi, F., Rajab, A., (2007), Lifestyle education and diabetes mellitus type 2: A non-randomized control trial, Iranian Journal Public Health, 36 (2).p. 68-72 ****Rubin RR (2000) Diabetes and quality of life from research to practice/ diabetes and quality of life, diabetes spectrum [online] 13 (1) [accessed 21 april 2006] p.21. available from world wide web:http://Journal.diabetes.org/diabetesspectrum/OOv13nl/pg21.html 3

other health issues, such as diabetes mellitus Community-Based Interactive Approach (CBIA ) Public education method, emphasizes on the active role of participants in looking for information in small group discussion. Has been proven effective in improving knowledge and skills: in selecting OTC medicines with impact in reducing OTC medicines in household*; of pharmacy assistant in hypertension drug information service**‏; in improving patients’ adherence to take medicines as recommended in tuberculosis***‏ CBIA is very potential to be developed as a model of public education in other health issues, such as diabetes mellitus DM club: as a hospital based patients community; has regular seminars every 2 months; Sundays meeting and exercises together; and as a media for sharing experiences _________________________________________________________________ *Suryawati, (2003), CBIA: Improving the quality of self-medication through mother active learning, Essential Drug monitor Issuer, No. 32, p.22-23, WHO, Geneva. **Astuti, A (1998) , Improving of knowledge and skill of Pharmacy assistant in hypertension drug information service inYogyakarta munipalcity, by using CBIA methods. Master thesis. Postgraduate program of faculty of medicines Gadjah Mada University. ***Susantini, A.,(2006), Improving tuberculosis patients’ adherence in taking medicine by using CBIA methods in Yogyakarta. Master thesis. Postgraduate program of faculty of medicines Gadjah Mada University. 4

OBJECTIVES OF THE STUDY General Objective Measuring the impact of CBIA-DM on type 2 diabetic patients’ knowledge, attitude, and practice towards diabetes self-care, as well as adherence to treatment program Specific objectives To measure the impact of CBIA-DM on patients’ knowledge, attitude and practice on diabetes self-care To measure the impact of CBIA-DM on patients’ adherence to treatment program To evaluate in general the effectiveness of CBIA-DM strategy 5

METHODS Study design: This is a pilot implementation study, applying a pre and post quasi-experimental design. The CBIA-DM intervention strategy was developed adapting the original CBIA* , enriched with key messages to improve type 2 diabetic patients’ adherence to treatment program. Setting: Panti Rapih and Panti Rini hospitals are charity hospitals in Yogyakarta- Indonesia which have diabetic clubs. Two groups of DM club member and / or family member of 2 different hospitals Intervention group : Underwent CBIA-DM (n=30)‏ Control group : Underwent Sundays meeting and exercises 2 Monthly regulars seminar (n=30)‏ Inclusion criteria of study population: Type 2 DM, DM club member and/or their family, literate, consented to the program and completed all activities required over the study period __________________________________________________________________________*Suryawati, (2003), CBIA: Improving the quality of self-medication through mother active learning, Essential Drug monitor Issuer, No. 32, p.22-23, WHO, Geneva. 6

Improving diabetic patients’ adherence to treatment program. Selecting of the strategy: CBIA: DM club: Diabetic patients gathering High learning motivation Utilizing gathering forum Needs for information Using training material Problem: Non adherence Effective in improving skills Effective in improving TBC patients’ adherence CBIA-DM Modified to improve adherence to DM treatment Improving diabetic patients’ adherence to treatment program. Diabetic patients’ scheduled-visits to hospital was used as a medium for rational used of medicines (RUM) education. 7

Developing of an educational material (CBIA-DM package) Draft was reviewed by experts Pilot test of the draft among selected members of DM club Results of FGD used for drafting educational material. Training of facilitators FGD among randomly selected members of diabetic club to obtain their needs for information. The educational material: CBIA-DM package (7 booklets) 7. Diet Program 4. Healthy Lifestyle 2. Issues of DM 1. Activities Guideline 3. About DM 5. Physical Activities 6. Foot Care 8

CBIA-DM activities (2 hours)‏: 1. Introduction: Explanation about the steps of program activities, Duration: 15 minutes 2. Small group discussion: 6 participants in each group, 5 groups involved in the study Facilitator: trained pharmacy students. Educational material: CBIA-DM packages. Duration : 90 minutes. 3. Summary and conclusion: By resource person. Duration: 15 minutes 9

Data collection and analysis‏ Using yes/no questions for knowledge level Practice indicators were assessed by patients’ diary and pill counting focus. When the number of remaining tablets was the same as the number of tablets supposed to be left on the counting date it was categorized as adhere. At 3 time points: pre intervention, post 2: week 2 and post 3: week 4 after intervention. Questionnaires were tested for validity by professionals’ (internist's, nutritionist and head of diabetic club) opinion or judgement. Reliability test was conducted by using Chronbach’s Alpha (α > 0.75). In-depth interviews were conducted among participants to obtain the impression regarding the program intervention. Intervention cost was calculated based on resource person’s fee, refreshment, meeting place and then compared to the cost of regular seminars in DM club (history) Data analysis: Comparisons of knowledge and practice scores for each group were analyzed by using Wilcoxon signed-rank test, while comparison of knowledge level between intervention and control group were analyzed by using the Kruskal-Wallis test and Mann-Whitney test. All p values obtained less than α=0.05 were considered as statistically significant. All data are presented as descriptive analytic in tables and figures

RESULTS 2. Improvement of practice scores Knowledge (Score = 0-11)‏ Variables CBIA Control Pre Post 2 Post 3 Mean *7.7 8.4 *8.6 7.1 7.5 7.4 SD 2.2 1.6 2.1 1.9 2.3 2. Improvement of practice scores 1. Improvement of knowledge scores *)‏ *)‏ Table 1. Comparison of Knowledge Scores Between CBIA-DM and Control Group *)‏ Wilcoxon test,*Sign.diff. (p=0.000)‏ Table 2. Comparison of Practice Scores Between CBIA-DM and Control Group 3. Increasing number of participants on adherence to treatment program 4. Time required for conducting CBIA-DM program was 2 hours, with cost US$ 4 per person cheaper than regular seminars in DM Club (US$ 8). 5. Participants and head of DM club expressed their appreciation to the program and mentioned that CBIA-DM program is easy to be followed and is enjoyable. Practice (Score = 0-11)‏ Variables CBIA Control Pre Post 2 Post 3 Mean *4.6 *6.0 5.4 6.4 SD 2.6 2.5 2.0 2.2 *)‏ *Wilcoxon test, significance p=0.000 *) Wilcoxon test p < 0.05 11

Summary CBIA-DM strategy showed significantly improved of diabetic knowledge, practice and adherence to treatment program Preparing training material was time consuming, however time required for conducting CBIA-DM strategy was only 2 hours Participants enjoyed all activities because the program was easy to be followed, and lead to participants felt more confident with their condition. Cost of intervention is cheaper than cost for conducting regular seminar in DM club These results indicated that the CBIA-DM strategy was capable of improving the adherence of participants in diabetes self-care

CONCLUSIONS and IMPLICATIONS CBIA-DM program is an effective, economic and enjoyable strategy to improve type 2 diabetic patients’ adherence to treatment program and is feasible to be implemented in hospital setting Repeating and developing the program is needed to sustain the impact of the CBIA-DM strategy Hospital-based patients community is possible to be used as a media for patients education and improving rationale used of medicines (RUM) Implications: CBIA-DM strategy can be used as patients’ empowerment in hospital setting CBIA-DM strategy can be used as a model for patients education in other chronic disease. 13

RECOMMENDATIONS CBIA-DM strategy will be successfully to be conducted in hospital-based patients community, when the activity is supported by: 1) The health care providers and staff, which can be gotten by: clearly explain to them about the objectives and the advantages of the program follow the hospital’s policy and procedure use the hospital’s events and schedules 2) Participants, which can be gotten through conducting an interesting program including: educational material dynamic of the program activities duration of the program activities do not create something new; for example new activities or new schedule that will lead to the participants’ inconvinience

ACKNOWLEDGEMENT The authors would like to thank to: The WHO-SEARO and the Sanata Dharma University Indonesia for financial support. Prof.Dr. Mohamed Izham Mohamed Ibrahim at the Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences University Sains Malaysia for the invaluable guidance, inspirations and advices Director and staff of the Panti Rapih and Panti Rini hospitals in Yogyakarta Indonesia, for the place permission to conduct the study All study participants and discussion facilitators who involved in this study This study has been presented in: The Inter country meeting of WHO-SEARO in New Delhi India, 13 – 15 July 2010, Funded by: WHO-SEARO. The 2nd International conference on Pharmacy and advance Pharmaceutical sciences, Gadjah Mada University Indonesia, 19-20 July 2011 Funded by: The Sanata Dharma University, Indonesia contact person: Titien Siwi Hartayu titien_hartayu@yahoo.com