FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/10/015962 [Registered on: 09/10/2018] Trial Registered Prospectively
Last Modified On: 19/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   A trial to study the effectiveness of Multi Component Behavioural Intervention programme on medication compliance and quality of life among elderly with chronic illness 
Scientific Title of Study   A community based Randomized Controlled Trial (RCT) to determine the efficiency of Multi-component Behavioral Intervention Programme (MBIP) on medication compliance and quality of life among elderly with chronic illness residing in selected rural areas of Udupi district, Karnataka. 
Trial Acronym  RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeyalakshmi K 
Designation  Assistant Professor - Senior scale 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886922100  
Fax    
Email  jeyalakshmi.k@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Elsa Sanatombi Devi 
Designation  Professor & HOD 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8310769938  
Fax    
Email  elsa.sana@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Mahadev Rao 
Designation  Professor & HOD 
Affiliation  MCOPS 
Address  Department of Pharmacy Practice, MCOPS, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8105706060  
Fax    
Email  mahadev.rao@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Nursing, MAHE, Manipal 
 
Primary Sponsor  
Name  Jeyalakshmi K 
Address  Manipal College of Nursing, MAHE, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Medical Officer PHC  Rural areas under PHC Udupi Taluk  Primary Health Center, Hirebettu, PHC Hireyadika, PHC Pernankila, PHC Kolalagiri, PHC Peradoor, PHC Manipura, PHC Kukkehalli PHC Pethri Udupi Taluk
Udupi
KARNATAKA 		 9448555448

phchirebettu@gmail.com 
MrsJeyalakshmi K  Rural areas under PHC Udupi Taluk  Department of Community Health Nursing, Manipal College of Nursing, MAHE, Manipal - 576104
Udupi
KARNATAKA 		 9886922100

jeyalakshmi.k@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College & Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I152||Hypertension secondary to endocrine disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi component Behavioural Intervetion Programme  Elderly with chronic illness in the selected study setting with medication non-compliance (based on the HBMAS score) will receive the interventional package of MBIP which includes medication education by using teach back technique Drug card Information Booklet SMS to Mobile Phone and its effectiveness will be determined in terms of medication compliance scores, improvement in bio-physiological values, increase in self -efficacy and quality of life scores on after 3, 6 & 12 months of MBIP.  
Comparator Agent  No Intervention  Elderly with chronic illness in the selected study setting with medication non-compliance (based on the HBMAS score) will be selected and do not receive interventions. These samples will be encouraged to follow their routine care and will be followed up and take the test after 3, 6, & 12th month of recruitment. The Education booklet on medication compliance will be given after the completion of data collection.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The rural area in villages which are covered by ASHA workers has more than 13 elderly with co-morbid conditions of hypertension and diabetes mellitus as on the survey data report.
Elderly in the age group of above 60 years in both gender who resides in selected rural areas of Udupi Taluk.
Elderly who is on prescribed medications for selected chronic illness.
Elderly and family care giver who can speak and understand English or Kannada.
Elderly with chronic illness or their care provider possess the mobile phone.
Elderly with chronic illness those who are willing to participate in this study.
Elderly with chronic illness and of either gender aged above 60 years receiving long term medications for more than 3 months.
 
 
ExclusionCriteria 
Details  Elderly those who could not follow the instructions of the investigator.
Elderly those who are not diagnosed to have any chronic illness and not having medications.
Elderly with chronic illness those who are newly diagnosed and taking medication less than 3 months for their conditions.
Elderly with chronic illness those who had a previous experience of being part of any other project related to drug compliance.
Elderly with any other major diagnosed co-morbid illness such as renal failure and other kidney disease, and other illness such as cancer in any situ, BPH, TB, HIV/AIDS.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome measures for Phase I:
Medication non-compliance of elderly with co-morbid chronic illnesses of hypertension and diabetes mellitus.
Outcome measures for Phase II:
Primary Outcome Measures:
Improvement in medication compliance (Hill Bone Medication Adhrernce scores) scores after 3, 6 and 12 months after applying MBIP.

 		 Baseline, 3, 6, 12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement on bio-physiological values (Blood sugar, HbA1, BP, Lipid Profile).
Increase in self-efficacy scores which will be measured by using MASES-R scale
Increase in quality of life scores which will be measured by using WHO-QOL BREF Scale
Client satisfaction and acceptability of the Multi-component Behavioral Intervention Programme (MBIP) by using rating scale.
 		 Baseline, 3, 6, 12 Months 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="480" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   20/11/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Title of the project:  A community based Randomized Controlled Trial (RCT) to determine the efficiency of Multi-component Behavioral Intervention Programme (MBIP) on medication compliance and quality of life among elderly with chronic illness residing in selected rural areas of Udupi district, Karnataka. 

BACKGROUND OF THE STUDY:

  • Globally, about 60% of the world’s elderly resides in developing countries (US Census Bureau 2000).
  • Population census data in India (2011) shows that, The elderly people (≥ 60 years) have increased up to 103.8 million in the year 2011 from 24.7 million in the year 1961 and there is wide range of difference in elderly people living in rural area (73.3 million) and in urban area (30.6 million).
  • Medication compliance is normally well-defined as the degree to which the patients follow the schedule of medications and other regimen which is recommended by their medical doctor (Beena Jimmy, & Jimmy Jose, 2011)
  • The medication regimen prescribed by the physician is intended to maintain the desired level of medications in the bloodstream to achieve the desired result (Marie T. Brown &  Jennifer K. Bussell, 2011)
  • Although medications are considered to be effective in managing the chronic diseases, gaps in medication compliance have been widely reported (Alexis A. Krumme et al., 2016).
  • Adherence to long term medications for chronic disease condition are poor among elderly patients (Marie T. Brown &  Jennifer K. Bussell, 2011)
  • The findings of a descriptive study which was conducted in Bangalore by R.Shruthi et al (2016) shows that, only 45.41% of geriatric patients had a good medication compliance among  251 elderly with chronic illness.
  • A single blinded Randomized Control Trial with the parallel assignment which was done in the clinical trial unit (CTU) in Aga Khan University, Karachi, Pakistan by Ayeesha Kamaran Kamal et al (2015) concludes that, SMS intervention are likely to improve the medication adherence among stroke patients. This study also recommends that, there is a need for future studies to report on meaningful biological outcomes.
  • Roter et al (1998), notified in their report of meta-analysis that, there is a need of extensive interventions relating cognitive, behavior and affective components than one single focused interventions.
  • The systematic review was performed by Walid F Gellad (2011) suggest for a future studies focusing on normalizing the measurements of medication adherence and also to enhance the further research to focus on assessing clinical outcome with medication adherence among elderly.
  • Monique van Eijken et al (2003) stated in their systematic review of RCTs on interventions to improve medication compliance among older patients that, multifaceted interventions may be more effective in presenting a change in medication compliance compared with control groups than single-focus interventions and there is a need of further studies having multiple intervention strategies to improve medication compliance.

Purpose of the Study:

The main purpose of this study is to identify the factors influencing medication non-compliance and to determine the efficiency of MBIP on medication compliance  among elderly with chronic illness in order to maintain their normal bio-physiological parameters and to enhance the self- efficacy and quality of life among them.  Thereby, this study further helps to reducing co-morbid conditions and mortality among elderly with chronic illness due to medication non-compliance in the rural community by enhancing their health literacy about their disease condition.

Aims & objectives:

     1. To assess the medication compliance in elderly with chronic illnesses and to find the factors influencing medication compliance among them

     2. To determine the effectiveness of  MBIP among elderly in terms of

-          improvement in medication compliance scores

-          improvement on bio-physiological values

-          increase in self-efficacy scores

-          increase in quality of life scores 

     3.  To assess the elderly satisfaction and acceptability of the MBIP

Hypotheses:

 All hypothesis will be tested at 0.05 level of significance.

H1        : There will be a significant improvement in the score of medication compliance among elderly with chronic illness in experimental group as compared to control group.

H2        : There will be significant improvement in bio-physiological values among elderly with chronic illness in experimental group as compared to control group.

H3        : There will be significant increase in the self-efficacy scores among elderly with chronic illness in experimental group as compared to control group.

H4        : There will be significant increase in the quality of life scores among elderly with chronic illness in experimental group as compared to control group.

Research approach:  Quantitative

Research Design:

Phase I: Descriptive survey

Phase II:  Randomized Controlled Trial (RCT)

Population:

o   The target population of this study will be elderly with chronic illnesses who are aged above 60 years residing in rural areas of Udupi Taluk.

Sample:  

o   Elderly with chronic illness who are aged above 60 years residing in selected rural areas of Udupi Taluk which are covered by the ASHA workers working under 8 selected PHCs and those who fulfills the sampling criteria.

Sample size :

  • Phase I  : 400
  • Phase II : 40 + 40 = 80

 Detailed description of procedure / processes:

 Phase I: Survey

o   House to house survey will be carried out by using willing ASHA workers under PHCs to quantify the elderly with chronic illness in the areas of ASHA workers’ coverage area.

o   Assessment of medication compliance and its associated factors among elderly with chronic illness.

Phase II: Intervention


A.     Teaching – learning:

·         Development and validation of instructional module by the investigator.

·         The pretest will be conducted after obtaining administrative permission and informed consent from the elderly with chronic illness.

·         Medication education will be given by using teach –back techniques after pre-test, followed by that, educational booklet will be given to the clients in the intervention group.

B.       Reinforcement:

·         The drug card will be given soon after medication education and thereafter once in a month. The investigator will explain on “how to maintain the drug card?” to all client while distributing to them.

·         SMS on client specific medication remainder and health information will be sent to their mobile phone by using the pre programmed software from 5th day of the medication intervention for 12 months. Medication remainder will be sent on everyday basis on set time and dietary and exercise remainder will be sent once in 2 days.

·         Follow –up in person or through telephone will be done for the clients to have consistent practice on medication, diet and exercise compliance, maintaining drug card and follow the educational pamphlet.

·         The post test will be conducted after 3, 6 & 12th month of MBIP.

Plan for data analysis:

Phase I (Survey): Descriptive statistics: Frequency and percentage, mean and standard deviation, Chi-sqare test

Phase II (RCT): Inferential statistics: Hypothesis will be tested by using parametric/non-parametric test based on the normality of the data

 
Close