Medication AdherenceMedAdh-RCTNCT03228706
Effectiveness of an Intervention in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in Malaysia
A study testing Know Your Medicine - Take It For Health (KYM-TIFH) in people with Medication Adherence and Type 2 Diabetes Mellitus, run by Clinical Research Centre, Malaysia at 2 sites in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Type 2 Diabetes Mellitus
- What is being tested?
- Know Your Medicine - Take It For Health (KYM-TIFH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Aug 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c > 7 %
- Malay T2DM patients > 18 years old
- Poor medication adherence (self-efficacy for appropriate medication use scale scoring < 26)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Kota Samarahan Health Clinic
Kota Samarahan, Sarawak, 94300
Petra Jaya Health Clinic
Kuching, Sarawak, 93050
About this study
Official title: Effectiveness of a Structured Group-Based Intervention "Know Your Medicine - Take It For Health" (KYM-TIFH) in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in the Sarawak State of Malaysia: A Randomized Controlled Trial
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.
Read the detailed description
A current systematic review by Odgers-Jewell et al (2017) revealed that little had been done to investigate the effectiveness of group based education in improving medication adherence among T2DM patients. This concur with the comprehensive review on interventions to improve medication adherence by Conn \& Ruppar (2017), as the researchers conclude that there is an urgent need in evaluating the interventions to improve medication adherence that employs group-based approach.
The evidence on the effectiveness of the KYM-TIFH in promoting medication adherence among T2DM patients remain lacking. Furthermore, the current measurement on the effectiveness of the campaign is the increment of the awareness level of public towards proper use of medicines (PSD 2013) without measuring the impact of the campaign on actual behavior change.
Besides aforementioned, Malay ethnic was found to be the main contributor to the prevalence of poor MA (PSD 2013) due to forgetfulness (75.3%) and reluctant to take prescribed medications (43.8%). Facing the high prevalence of poor MA among Malay patients, an effective and efficient approach which could engage more patients within a shorter period of times to improve the medication adherence problems is highly preferred (Odgers-Jewell 2017). Hence, all the problem statements addressed above lead to the necessity of conducting this study, which aims to investigate the effectiveness of the SGBI "KYM-TIFH" in improving MA among Malay patients with T2DM.
Based on the problems stated above, this study aims (1) to measure the effectiveness of MEDIHEALTH in improving the medication adherence level and the component of the extended TPB, (2) to identify the component of the extended TPB that predicts medication adherence after participating in MEDIHEALTH, and (3) to investigate the sustainability of the program.
Based on the first specific objective, ten hypotheses are to be tested:
H1a: Increase in intention to adhere would be mediated by improvements in attitude towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1b: Increase in intention to adhere would be mediated by improvements in subjective norm towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1c: Increase in medication adherence would be mediated by improvements in intention to adhere after baseline, which is achieved by participating in MEDIHEALTH.
H1d: Increase in intention to adhere would be mediated by improvements in perceived behavioural control towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1e: Increase in intention to adhere would be mediated by improvements in adherence information after baseline, which is achieved by participating in MEDIHEALTH.
H1f: Before the intervention, there are no significant differences of medication adherence level and the psychosocial variables related to it among the participants between the intervention group and the control group.
H1g: After 3, 6 and 12 months of the program, the medication adherence levels among the participants in the intervention group are significantly greater than the medication adherence levels before the intervention.
H1h: After 3, 6 and 12 months of the program, the medication adherence levels among the participants in the intervention group are significantly greater than the medication adherence levels of the participants in the control group.
H1i: After 3, 6 and 12 months of the program, the HbA1c levels among the participants in the intervention group are significantly greater than the HbA1c before the intervention.
H1j: After 3, 6 and 12 months of the program, the HbA1c levels among the participants in the intervention group are significantly greater than the HbA1c levels of the participants in the control group.
For the second specific objective, eight hypotheses are to be tested:
H2a: Improvement in attitude towards adherence will contribute to the increase in intention to adhere.
H2b: Improvement in subjective norm towards adherence will contribute to the increase in intention to adhere.
H2c: Improvement in perceived behavioural control towards adherence will contribute to the increase in intention to adhere.
H2d: Improvement in perceived behavioural control towards adherence will contribute to the increase in medication adherence.
H2e: Improvement in intention to adhere will contribute to the increase in medication adherence.
H2f: Improvement in adherence information will contribute to the increase in perceived behavioural control towards adherence.
H2g: Improvement in adherence information will contribute to the increase in medication adherence.
H2i: Improvement in medication adherence level will contribute to the decrease in HbA1c level.
Operational definitions:
- Medication adherence: Medication adherence is defined as the level of patients in complying with the medications prescribed by healthcare providers. Such level of compliance is measured through 13 items self-efficacy for appropriate medication use scale (Risser et al., 2007) which had been validated among chronic patients with low literacy.
- T2DM Malay patients: Type 2 Diabetes Mellitus Malay patients of this study refers to all the patients who are prescribed with oral anti-hyperglycaemic agents (OHA) and obtain their medications supply from the pharmacy department of Kota Samarahan Health Clinic (KS-HC) and Petra Jaya Health Clinic (PJ-HC) during the study period. Such T2DM patients whose identity card show their religion as Islam, will be considered as Malay T2DM patients for this study.
- Structured group based intervention: The structured group based intervention of this study refers to the program "Know Your Medicine - Take it for Health" which was formulated and employed by the Pharmaceutical Services Division of Sarawak State Health Department in late 2016 under the national campaign "Know Your Medicine" to promote medication adherence among T2DM Malay patients. The official name of the intervention is "Kenali Ubat Anda - Ambillah untuk Kesihatan" in Malay language or "Know Your Medicine - Take it for Health" in English with abbreviation KYM-TIFH.
- Effectiveness: The effectiveness of this study refers to the improvement of HbA1c and medication adherence level among T2DM Malay patients before and after the SGBI with such improvement having a significant difference as compared to the results in control group. Furthermore, the effectiveness of the SGBI will be complemented by the qualitative data through focus group discussion and a semi-structured interview.
- Complications: The complications in this study refers to the diabetes-related complications including retinopathy, nephropathy, diabetic foot problems, ischemic heart disease and stroke that had been diagnosed by doctors and were documented in patients' medical records during the period of study.
- Conditions
- Medication Adherence, Type 2 Diabetes Mellitus
- Being tested
- Know Your Medicine - Take It For Health (KYM-TIFH)
- Keywords
- Type 2 Diabetes Mellitus, Medication Adherence, Malay patients, Structured Group-Based Intervention, Randomised controlled trial
- Medical subject headings
- Medication Adherence, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Know Your Medicine - Take It For Health (KYM-TIFH)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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).
Measured: 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.
The adherence Information is measured using a 6 items 5 points Likert scale adopted from McPherson et al. (2008). It is measured right before the interventional program begin and right after the interventional program finish.
Measured: 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.
The attitude towards medication adherence is measured using a 5 items 5 points Likert scale adopted from Farmer et al. (2006). It is measured right before the interventional program begin and right after the interventional program finish.
Measured: 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.
The subjective norms towards medication adherence is measured using a 6 items 5 points Likert scale adopted from Farmer et al. (2006). It is measured right before the interventional program begin and right after the interventional program finish.
Measured: 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.
The perceived behavioural control towards medication adherence is measured using a 11 items 5 points Likert scale adopted from Fernandez et al. (2008). It is measured right before the interventional program begin and right after the interventional program finish.
Measured: 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.
The intention to adhere is measured using a 3 items 5 points Likert scale adopted from Vissman et al. (2013). It is measured right before the interventional program begin and right after the interventional program finish.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University Malaysia Sarawak
- Responsible party
- Principal investigator, Ting Chuo Yew, Clinical Research Centre, Malaysia
- Investigators
- Ting Chuo Yew, MPhil, Principal investigator, Sarawak Pharmacy Enforcement Division, Sarawak State Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228706
- Sponsor's protocol ID
- 35875
- Acronym
- MedAdh-RCT
- Status last verified
- Mar 2020
- First submitted
- 18 May 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers as only aggregated data will be used for the study.
Publications
Ajzen, I. (1991). The theory of planned behavior. Organizational behavior and human decision processes, 50(2), 179-211.
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.
PubMed 23990497Capoccia 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.
PubMed 26637240Meng 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.
PubMed 28345434Alrasheedy 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.
PubMed 28222951Slater, 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.
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.
PubMed 28226200Conn 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.
PubMed 28315760Puffer 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.
PubMed 16164589Chan 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.
PubMed 23303884Campbell 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.
PubMed 22951546Borek 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.
PubMed 26403082Fisher 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.
PubMed 16846321Risser 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.
PubMed 18232619Ting 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.
PubMed 29871651
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Structured Group-Based Intervention "Know Your Medicine - Take It For Health" (KYM-TIFH) in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in the Sarawak State of Malaysia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03228706
- Acronym / sponsor ID
- MedAdh-RCT / 35875
- Conditions
- Medication Adherence, Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Medication Adherence, Malay patients, Structured Group-Based Intervention, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- University Malaysia Sarawak
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A current systematic review by Odgers-Jewell et al (2017) revealed that little had been done to investigate the effectiveness of group based education in improving medication adherence among T2DM patients. This concur with the comprehensive review on interventions to improve medication adherence by Conn \& Ruppar (2017), as the researchers conclude that there is an urgent need in evaluating the interventions to improve medication adherence that employs group-based approach.
The evidence on the effectiveness of the KYM-TIFH in promoting medication adherence among T2DM patients remain lacking. Furthermore, the current measurement on the effectiveness of the campaign is the increment of the awareness level of public towards proper use of medicines (PSD 2013) without measuring the impact of the campaign on actual behavior change.
Besides aforementioned, Malay ethnic was found to be the main contributor to the prevalence of poor MA (PSD 2013) due to forgetfulness (75.3%) and reluctant to take prescribed medications (43.8%). Facing the high prevalence of poor MA among Malay patients, an effective and efficient approach which could engage more patients within a shorter period of times to improve the medication adherence problems is highly preferred (Odgers-Jewell 2017). Hence, all the problem statements addressed above lead to the necessity of conducting this study, which aims to investigate the effectiveness of the SGBI "KYM-TIFH" in improving MA among Malay patients with T2DM.
Based on the problems stated above, this study aims (1) to measure the effectiveness of MEDIHEALTH in improving the medication adherence level and the component of the extended TPB, (2) to identify the component of the extended TPB that predicts medication adherence after participating in MEDIHEALTH, and (3) to investigate the sustainability of the program.
Based on the first specific objective, ten hypotheses are to be tested:
H1a: Increase in intention to adhere would be mediated by improvements in attitude towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1b: Increase in intention to adhere would be mediated by improvements in subjective norm towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1c: Increase in medication adherence would be mediated by improvements in intention to adhere after baseline, which is achieved by participating in MEDIHEALTH.
H1d: Increase in intention to adhere would be mediated by improvements in perceived behavioural control towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1e: Increase in intention to adhere would be mediated by improvements in adherence information after baseline, which is achieved by participating in MEDIHEALTH.
H1f: Before the intervention, there are no significant differences of medication adherence level and the psychosocial variables related to it among the participants between the intervention group and the control group.
H1g: After 3, 6 and 12 months of the program, the medication adherence levels among the participants in the intervention group are significantly greater than the medication adherence levels before the intervention.
H1h: After 3, 6 and 12 months of the program, the medication adherence levels among the participants in the intervention group are significantly greater than the medication adherence levels of the participants in the control group.
H1i: After 3, 6 and 12 months of the program, the HbA1c levels among the participants in the intervention group are significantly greater than the HbA1c before the intervention.
H1j: After 3, 6 and 12 months of the program, the HbA1c levels among the participants in the intervention group are significantly greater than the HbA1c levels of the participants in the control group.
For the second specific objective, eight hypotheses are to be tested:
H2a: Improvement in attitude towards adherence will contribute to the increase in intention to adhere.
H2b: Improvement in subjective norm towards adherence will contribute to the increase in intention to adhere.
H2c: Improvement in perceived behavioural control towards adherence will contribute to the increase in intention to adhere.
H2d: Improvement in perceived behavioural control towards adherence will contribute to the increase in medication adherence.
H2e: Improvement in intention to adhere will contribute to the increase in medication adherence.
H2f: Improvement in adherence information will contribute to the increase in perceived behavioural control towards adherence.
H2g: Improvement in adherence information will contribute to the increase in medication adherence.
H2i: Improvement in medication adherence level will contribute to the decrease in HbA1c level.
Operational definitions:
- Medication adherence: Medication adherence is defined as the level of patients in complying with the medications prescribed by healthcare providers. Such level of compliance is measured through 13 items self-efficacy for appropriate medication use scale (Risser et al., 2007) which had been validated among chronic patients with low literacy.
- T2DM Malay patients: Type 2 Diabetes Mellitus Malay patients of this study refers to all the patients who are prescribed with oral anti-hyperglycaemic agents (OHA) and obtain their medications supply from the pharmacy department of Kota Samarahan Health Clinic (KS-HC) and Petra Jaya Health Clinic (PJ-HC) during the study period. Such T2DM patients whose identity card show their religion as Islam, will be considered as Malay T2DM patients for this study.
- Structured group based intervention: The structured group based intervention of this study refers to the program "Know Your Medicine - Take it for Health" which was formulated and employed by the Pharmaceutical Services Division of Sarawak State Health Department in late 2016 under the national campaign "Know Your Medicine" to promote medication adherence among T2DM Malay patients. The official name of the intervention is "Kenali Ubat Anda - Ambillah untuk Kesihatan" in Malay language or "Know Your Medicine - Take it for Health" in English with abbreviation KYM-TIFH.
- Effectiveness: The effectiveness of this study refers to the improvement of HbA1c and medication adherence level among T2DM Malay patients before and after the SGBI with such improvement having a significant difference as compared to the results in control group. Furthermore, the effectiveness of the SGBI will be complemented by the qualitative data through focus group discussion and a semi-structured interview.
- Complications: The complications in this study refers to the diabetes-related complications including retinopathy, nephropathy, diabetic foot problems, ischemic heart disease and stroke that had been diagnosed by doctors and were documented in patients' medical records during the period of study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Know Your Medicine - Take It For Health (KYM-TIFH)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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HbA1c > 7 %
- Malay T2DM patients > 18 years old
- Poor medication adherence (self-efficacy for appropriate medication use scale scoring < 26)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Know Your Medicine - Take It For Health (KYM-TIFH)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. | Behavioural | Intervention Group |
Primary outcome
Change of HbA1c level at baseline, and at 3, 6 and 12 months after intervention.
Time frame: Measured during the recruitment of participants and after 3, 6 and 12 months of the intervention.
The HbA1c level before the intervention and after three, six and twelve months of the intervention.
Change of medication adherence at baseline, and at 3, 6 and 12 months after intervention.
Time frame: 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
The medication adherence is measured by self-efficacy for appropriate medication use scale (Risser et al., 2007).
5 secondary outcomes
Change of adherence information at baseline, and at 3, 6 and 12 months after intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- BackgroundAjzen, I. (1991). The theory of planned behavior. Organizational behavior and human decision processes, 50(2), 179-211.
- Background: PubMed 23990497Garcia-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.
- Background: PubMed 26637240Capoccia 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.
- Background: PubMed 28345434Meng 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.
- Background: PubMed 28222951Alrasheedy 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.
- BackgroundSlater, 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: PubMed 28226200Odgers-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.
- Background: PubMed 28315760Conn 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.
- Background: PubMed 16164589Puffer 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.
- Background: PubMed 23303884Chan 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.
- Background: PubMed 22951546Campbell 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.
- Background: PubMed 26403082Borek 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.
- National Use of Medicine Survey by Pharmaceutical Services Division, Ministry of HealthLink provided by the sponsor.
- Drug Utilization in the Treatment of Diabetes Mellitus in the Ministry of Health FacilitiesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers as only aggregated data will be used for the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Chuo Yew, MPhil principal investigator
Sarawak Pharmacy Enforcement Division, Sarawak State Health Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Know Your Medicine - Take It For Health (KYM-TIFH) in people with Medication Adherence and Type 2 Diabetes Mellitus, run by Clinical Research Centre, Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1c level at baseline, and at 3, 6 and 12 months after intervention. (time frame: Measured during the recruitment of participants and after 3, 6 and 12 months of the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228706, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.