Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03228706
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2017-05-18
Brief Title:
Effectiveness of an Intervention in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in Malaysia
Sponsor:
Clinical Research Centre Malaysia
Organization:
Clinical Research Centre Malaysia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MedAdh-RCT
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
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 753 and reluctant to take prescribed medications 438 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
1 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
2 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
3 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
4 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
5 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
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 753 and reluctant to take prescribed medications 438 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
1 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
2 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
3 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
4 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
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None