Effectiveness of an Intervention in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in Malaysia

NCT03228706 | Completed

• 1 other identifier: 35875
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

Poor medication adherence (MA) among Type 2 Diabetes Mellitus (T2DM) patients had found to be gnarly and devastating (Krass et al 2015; Sharma et al 2014). It was estimated that more than half of the patients failed to achieve recommended glycaemic goals due to nonadherence (García-Pérez 2013; World Health Organization 2003). Furthermore, greater adherence rate was significantly associated with better glycemic control, fewer hospital visits and admissions, and lower medical costs. On the other hand, lower adherence rate was significantly associated with poor medication tolerance, the frequency of medication intake (\> 2 times a day), having concomitant depression and negative belief about the medications. Consequently, patients who poorly adhere to medications would take more medications due to the poor glycemic control and development of micro- and macrovascular complications (American Diabetes Association 2013). Such condition would further worsen their adherence due to more complex medications and a greater chance of experiencing drug-related side effects (García-Pérez 2013). This inevitably increases the economic burden and wastage to the healthcare system (Meng et al 2017). Hence breaking the vicious cycle is an urgent call to all stakeholders. Notably, Ministry of Health Malaysia (MOH) had initiated several interventions in curbing the MA problems at national level. One of those which has been perpetuated and led by pharmacists is "Know Your Medicine" (KYM) Campaign since 2007. The national KYM campaign aims to promote the quality use of medicines through mass communication and group-based approach. The messages conveyed include information on their medication management such as why, how and when to take medicines, reporting adverse drug events, awareness on the rational use of medicines and medications that need special precautions. In specific, assuring and improving medication adherence among patients is one of the important components of the campaign (PSD 2008). In term of improving medication adherence among Malay T2DM patients, a structured group-based intervention (SGBI) called "Know Your Medicine - Take It For Health" with abbreviation KYM-TIGF, was created by the researchers of this study who work at Sarawak Pharmaceutical Services Division in 2016 under the KYM campaign. The KYM-TIGF is a theoretical based, patient empowerment, culturally appropriate and a combination of psychosocial, educational and behavioral intervention. It is a one-off SGBI that aims to improve the medication adherence through the message specially designed with a cross-theoretical framework as recommended by Slater (1999). The model to measure the effectiveness of the SGBI is an integrated model with Theory of Planned Behaviour (Ajzen 1991) as main theory and Information-Motivation-Behavioural Skills Model (Fisher et al. 2006) as supporting theory. The primary outcome of this study is the HbA1c. The secondary outcomes of this study are the medication adherence level as well as the psychosocial variables of the integrated model which include attitude to medication adhere, the subjective norm to medication adherence, perceived behavioral control towards medication adherence, adherence information, adherence skill and intention to adhere.

Conditions

Medication Adherence; Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Medication Adherence; Malay patients; Structured Group-Based Intervention; Randomised controlled trial

Outcome Measures

Primary Outcomes (2)

• Change of HbA1c level at baseline, and at 3, 6 and 12 months after intervention.

  The HbA1c level before the intervention and after three, six and twelve months of the intervention.

  Measured during the recruitment of participants and after 3, 6 and 12 months of the intervention.

• Change of medication adherence at baseline, and at 3, 6 and 12 months after intervention.

  The medication adherence is measured by self-efficacy for appropriate medication use scale (Risser et al., 2007).

  Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program

Secondary Outcomes (5)

• Change of adherence information at baseline, and at 3, 6 and 12 months after intervention.

  Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program

• Change of attitude towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.

  Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program

• Change of subjective norms towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.

  Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program

• Change of perceived behavioural control towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.

  Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program

• Change of intention to adhere at baseline, and at 3, 6 and 12 months after intervention.

  Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program

Other Outcomes (2)

• Qualitative evaluation on the effectiveness of the program

  The selected participants will be interviewed upon 1 month after the program

• Sustainability of the Program

  Two main facilitators and the two managerial officers will be interviewed at 12 months after the program

Study Arms (2)

Intervention Group

EXPERIMENTAL

All the participants who are randomly assigned to the intervention group will be undergoing the Know Your Medicine-Take it for Health (KYM-TIFH) program, which is a one-off structured group-based intervention (SGBI).

Behavioral: Know Your Medicine - Take It For Health (KYM-TIFH)

Control Group

NO INTERVENTION

All the participants who are randomly assigned to the control group will not be given any information related to KYM-TIFH. However, they will be assigned to the venue for the control group and will be asked to fill in questionnaires with the assistance of four facilitators. A briefing on how to answer the questionnaire will be given by the main facilitator and all facilitators are allowed to answer any questions raised by respondents related to the questionnaire. However, they are not allowed to answer on behalf of the respondents. After the completion of the questionnaire, they will be informed about the subsequent follow-up measurement after three, six and twelve months. After that, they will be dismissed and having usual care provided by the health clinic as before without any changes.

Interventions

Know Your Medicine - Take It For Health (KYM-TIFH) BEHAVIORAL

The KYM-TIFH employed psychosocial, educational and behavioral approach. It was designed based on the application of multiple behavior change theories and persuasion theory as recommended by Slater (1999). The cross-theoretical framework for the message design of intervention as recommended by Slater (1999) involved theories such as Transtheoretical Model (TTM) (Prochaska \& Velicer 1997), Theory of Reasoned Action (TRA) (Ajzen \& Fishbein 1980), Protection Motivation Theory (PMT) (Rogers 1975), Elaboration-Likelihood Model (ELM) (Petty and Cacioppo 1986) and Social Cognitive Theory (SCT) (Bandura 1992) as in Table 2. Nonetheless, the intervention embraces the philosophy of patients' empowerment, which had found to be effective in engaging patients to produce behavioral change among diabetes patients (Anderson 1995; Anderson et al 1995). Hence, the facilitators are trained to employ a non-didactic approach in facilitating the and eliciting the learning among the group members.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1c \> 7 %
• Malay T2DM patients \> 18 years old
• Poor medication adherence (self-efficacy for appropriate medication use scale scoring \< 26)

You may not qualify if:

• Pregnant Women
• Patients less than 18 years old
• Patients who had severe and enduring mental health problems
• Patients who can't listen or read due to inherited disabilities or malfunction
• Patients who unable to communicate in the Malay language
• Patients who are participating in other studies
• Patients who decline the consent to participate
• Hospitalized

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead
• University Malaysia Sarawak: collaborator

Study Sites (2)

Kota Samarahan Health Clinic

Kota Samarahan, Sarawak, 94300, Malaysia

Location

Petra Jaya Health Clinic

Kuching, Sarawak, 93050, Malaysia

Location

Related Publications (15)

• Ajzen, I. (1991). The theory of planned behavior. Organizational behavior and human decision processes, 50(2), 179-211.

  BACKGROUND

• Garcia-Perez LE, Alvarez M, Dilla T, Gil-Guillen V, Orozco-Beltran D. Adherence to therapies in patients with type 2 diabetes. Diabetes Ther. 2013 Dec;4(2):175-94. doi: 10.1007/s13300-013-0034-y. Epub 2013 Aug 30.

  PMID: 23990497 BACKGROUND

• Capoccia K, Odegard PS, Letassy N. Medication Adherence With Diabetes Medication: A Systematic Review of the Literature. Diabetes Educ. 2016 Feb;42(1):34-71. doi: 10.1177/0145721715619038. Epub 2015 Dec 4.

  PMID: 26637240 BACKGROUND

• Meng J, Casciano R, Lee YC, Stern L, Gultyaev D, Tong L, Kitio-Dschassi B. Effect of Diabetes Treatment-Related Attributes on Costs to Type 2 Diabetes Patients in a Real-World Population. J Manag Care Spec Pharm. 2017 Apr;23(4):446-452. doi: 10.18553/jmcp.2017.23.4.446.

  PMID: 28345434 BACKGROUND

• Alrasheedy AA, Hassali MA, Wong ZY, Saleem F. Pharmacist-managed medication therapy adherence clinics: The Malaysian experience. Res Social Adm Pharm. 2017 Jul-Aug;13(4):885-886. doi: 10.1016/j.sapharm.2017.02.011. Epub 2017 Feb 16. No abstract available.

  PMID: 28222951 BACKGROUND

• Slater, M. D. (1999). Integrating application of media effects, persuasion, and behavior change theories to communication campaigns: A stages-of-change framework. Health Communication, 11(4), 335-354.

  BACKGROUND

• Odgers-Jewell K, Ball LE, Kelly JT, Isenring EA, Reidlinger DP, Thomas R. Effectiveness of group-based self-management education for individuals with Type 2 diabetes: a systematic review with meta-analyses and meta-regression. Diabet Med. 2017 Aug;34(8):1027-1039. doi: 10.1111/dme.13340. Epub 2017 Mar 20.

  PMID: 28226200 BACKGROUND

• Conn VS, Ruppar TM. Medication adherence outcomes of 771 intervention trials: Systematic review and meta-analysis. Prev Med. 2017 Jun;99:269-276. doi: 10.1016/j.ypmed.2017.03.008. Epub 2017 Mar 16.

  PMID: 28315760 BACKGROUND

• Puffer S, Torgerson DJ, Watson J. Cluster randomized controlled trials. J Eval Clin Pract. 2005 Oct;11(5):479-83. doi: 10.1111/j.1365-2753.2005.00568.x.

  PMID: 16164589 BACKGROUND

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

  PMID: 23303884 BACKGROUND

• Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.

  PMID: 22951546 BACKGROUND

• Borek AJ, Abraham C, Smith JR, Greaves CJ, Tarrant M. A checklist to improve reporting of group-based behaviour-change interventions. BMC Public Health. 2015 Sep 25;15:963. doi: 10.1186/s12889-015-2300-6.

  PMID: 26403082 BACKGROUND

• Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006 Jul;25(4):462-73. doi: 10.1037/0278-6133.25.4.462.

  PMID: 16846321 BACKGROUND

• Risser J, Jacobson TA, Kripalani S. Development and psychometric evaluation of the Self-efficacy for Appropriate Medication Use Scale (SEAMS) in low-literacy patients with chronic disease. J Nurs Meas. 2007;15(3):203-19. doi: 10.1891/106137407783095757.

  PMID: 18232619 BACKGROUND

• Ting CY, Ahmad Zaidi Adruce S, Hassali MA, Ting H, Lim CJ, Ting RS, Abd Jabar AHA, Osman NA, Shuib IS, Loo SC, Sim ST, Lim SE, Morisky DE. Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial. Trials. 2018 Jun 5;19(1):310. doi: 10.1186/s13063-018-2649-9.

  PMID: 29871651 DERIVED

Related Links

• National Use of Medicine Survey by Pharmaceutical Services Division, Ministry of Health
• Drug Utilization in the Treatment of Diabetes Mellitus in the Ministry of Health Facilities

MeSH Terms

Conditions

Medication Adherence; Diabetes Mellitus, Type 2

Interventions

Health

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Ting Chuo Yew, MPhil

  Sarawak Pharmacy Enforcement Division, Sarawak State Health Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A person who is independent of this study and invited by principal investigator will carry out the randomization based on the list of participants who are eligible and agreed to participate. The list of participants with their randomization information will be kept by the committee member without informing any of the researchers including principal investigator or respondents to assure the blinding of both parties throughout the study. On the day of the intervention, that person will register the attendance of respondents and inform them about the actual venue of the program without informing the researchers or the facilitators of the KYM-TIFH. Each HCKS and HCKS will have two venues prepared and available during the period of the study with one venue allocated for intervention group and the other one with for control group. None of the respondents were aware of the difference between the with assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Assistant Director (Pharmacy Enforcement)

Model Details: To achieve the objectives, positivist approach with experimental study design will be employed. In specific, it is a double blinded, randomized controlled trial (RCT) which involve two study sites. Nonetheless, the reporting of the SGBI will be in accordance with the checklist recommended by Borek et al. (2015).

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: July 25, 2017
• Study Start: August 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)