A trial to study the effectiveness of Multi Component Behavioural Intervention programme on medication compliance and quality of life among elderly with chronic illness
- Conditions
- Hypertension secondary to endocrine disorders,
- Registration Number
- CTRI/2018/10/015962
- Lead Sponsor
- Jeyalakshmi K
- 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 & 12thmonth 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 480
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome measures for Phase I: Baseline, 3, 6, 12 Months Medication non-compliance of elderly with co-morbid chronic illnesses of hypertension and diabetes mellitus. Baseline, 3, 6, 12 Months Outcome measures for Phase II: Baseline, 3, 6, 12 Months Primary Outcome Measures: Baseline, 3, 6, 12 Months 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Rural areas under PHC Udupi Taluk
🇮🇳Udupi, KARNATAKA, India
Rural areas under PHC Udupi Taluk🇮🇳Udupi, KARNATAKA, IndiaMedical Officer PHCPrincipal investigator9448555448phchirebettu@gmail.comMrsJeyalakshmi KPrincipal investigator9886922100jeyalakshmi.k@manipal.edu