Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
01 / Name of candidate and address(in block letters) / HIRAL KIRITBHAI PATEL,
# 228, 45TH CROSS,
8TH BLOCK,
JAYA NAGAR,
BANGALORE- 560082
02 /
Name of institution
/ Al-Ameen College of Pharmacy,Hosur Road, Bangalore- 560027
03 /
Course of study and subject
/ M. PharmPharmacy Practice
04 / Date of admission to course / 9th JUNE 2009
05 /
Title of the Topic:
“ STUDY OF IMPACT OF PATIENT EDUCATION ON THE QUALITY OF LIFE OF ASTHMA PATIENTS AT ST. MARTHA’S HOSPITAL, BANGALORE ”
06 /
BRIEF RESUME OF THE INTENDED WORK
6.1 / Need for the studyAsthma is defined as a chronic inflammatory disease of airways that is characterized by increased responsiveness of the tracheobronchial tree to a multiplicity of stimuli. It is manifested physiologically by a widespread narrowing of the air passages, which may be relieved spontaneously or as a result of therapy, and clinically by paroxysms of dyspnea, cough, and wheezing. The stimuli that incite acute episodes of asthma can be grouped into seven major categories: allergenic, pharmacologic, environmental, occupational, infectious, exercise related, and emotional. Bronchial asthma occurs at all ages but predominantly in early life.1
The patient may complain of episodes of dyspnea, chest tightness, coughing (particularly at night), wheezing, or a whistling sound when breathing. These often occur in association with exercise, but also occur spontaneously or in association with known allergens.2 Asthma is a highly variable disease. Some patients have extended symptom-free periods between episodes and experience symptoms only when they exercise or are exposed to allergens or viral respiratory tract infections. Other patients have continuous symptoms or frequent recurrent acute episodes. The pattern of symptoms varies among patients.3
Worldwide, an estimated 300 million people suffer from asthma and it is a major health problem worldwide.4
The primary goal of treatment is prevention of life-threatening asthma by early recognition of signs of deterioration and early intervention. As such, the principal goals of treatment include.
- Correction of significant hypoxemia
- Education regarding patient’s illness, correct method of taking treatment and preventive
measures
- Rapid reversal of airflow obstruction
- Reduction of the likelihood of recurrence of severe airflow obstruction
- Development of a written action plan in case of a further exacerbation
These goals are best achieved by early initiation of treatment and close monitoring of objective measures of oxygenation and lung function.2
The agents for treating asthma can be divided into two general categories: drugs that inhibit smooth-muscle contraction, i.e., the so-called “quick relief medications” like adrenergic-agonists, methylxanthines, and anticholinergics and agents that prevent and/or reverse inflammation, i.e., the “long-term control medications” like glucocorticoids, long-acting β2-agonists, combined medications, mast cell–stabilizing agents, leukotriene modifiers, and methylxanthines.1
Asthma continues to be under-diagnosed and under-treated, its appropriate management requires correct diagnosis, assessment of severity, proper management including appropriate medication, patient education, and a written action plan, ongoing monitoring, appropriate follow-up, and specialty referral where appropriate.
The current guidelines for treatment of asthma recommend greater involvement of the patients in the management of their diseases. Self management of asthma is reported to reduce its frequent recurrence and improve patients’ quality of life. Self-management skills should be developed through education of the patients regarding his illness and information of treatment modalities is now an important aspect of pharmaceutical care under the guidance of a clinical pharmacist. 5
There is a huge gap in the goals of asthma management and the reality scenario. Asthma education to patients may bridge the gap.4 Patient education is essential in the long-term success of asthma management and pharmacists can educate patients by providing information about asthma medications and by demonstrating how to use inhaled medications and to monitor peak expiratory flow rate using peak flow meter. They can help patients to understand their asthma management plan. In addition, pharmacists can monitor medications use, compliance and refer patients with poor control of asthma to physicians for increasing or decreasing level of asthma medication. Pharmacist interventions have been shown to improve medication usage and asthma morbidity.5
In view of the above, it is proposed to counsel and educate the patients regarding the management of asthma and assess the impact of the same on their quality of life at St. Martha’s Hospital, Bangalore.
6.2 /
Review of literature
Asthma prescription requires the use of inhaled medications. Drugs such as anticholinergics, β2 agonists and steroids are used in the form of inhalers. Use of inhaler is an important aspect in treatment of asthma, improper use may result in untreated asthma with serious complications. Many patients find it difficult to use metered dose inhaler appropriately and hence arises a need to educate them for the same.
A prospective, randomized, controlled study was conducted in Shaab teaching hospital, Khartoum, Sudan for the period of a year. Patients were allocated randomly either in the intervention group (60) or control group (40) patients. Intervention patients received comprehensive medication counselling and asthma education every 2 weeks, while the control group received the routine medical consultation and dispensing services. The intervention patients had shown significant improvement on the frequency of acute attacks of asthma, reduction in the occurrence of nocturnal asthma symptoms, the use of inhaled beta2-agonists, the days of sickness and rate of hospitalization. The present study has shown that a trained pharmacist has a positive role in enhancement of effective treatment and monitoring of asthma patients, and in the provision of appropriate health care education.5
A 6-month randomised, controlled, parallel-group study was conducted in 66 community pharmacies in Belgium. Patients were randomly assigned to receive usual pharmacist care or a pre-defined pharmacist intervention. This intervention mainly focused on improving inhalation technique and medication adherence. Primary outcome was the level of asthma control, as assessed by the Asthma Control Test1 (ACT). Inhalation technique and adherence to controller medication were significantly better in the intervention group. The clear need for patient-focused care on appropriate use of asthma medication has already been highlighted and it is an essential strategy to improve asthma control, especially in primary care.6
A randomized, controlled, longitudinal, prospective study was carried out to implement and assess a community-based pharmaceutical care program for patients with asthma. A total of 152 patients were recruited to participate in the study: 86 in the intervention group and 66 in the control group. Parameters assessed at baseline and at 4, 8, and 12 months were health-related quality of life, peak expiratory flow (PEF), inhaler technique, compliance with therapy, hospitalization rates, days lost from work, asthma symptoms, and patient satisfaction. This study represented a major change in conventional practice for pharmacists. A community-based pharmaceutical care program was appreciated by the participants and had a positive impact on the vitality of patients with asthma, inhaler technique, PEF and self reported hospitalisation.7
A study included counseling of 1105 patients by pharmacists at Medication Counseling Center (MMC) in Manipal Teaching Hospital, Nepal from September 2004 till August 2007. Pharmacists used ‘compliance aids’ like ‘medication envelops’ (52%), followed by ‘medication calendar’ (0.63 %) and Leaflets (0.09) in order to improve the compliance following the counseling. The most commonly used counseling aids were nasal sprays, metered dose inhalers (MDI) and rotahalers. Counseling patients with MDI is very essential. It has been shown that approximately 75% of the patients using MDIs do not take them properly. From the study, it was concluded that pharmacists can provide counseling to the patients through medication counseling centers. This may in turn improve patient adherence, which is one of the common causes for therapeutic failures in countries like Nepal.8
A randomized controlled trial was conducted ay 36 community drugstore in Indianapolis, Ind to assess the effect of a pharmaceutical care program for patients with asthma or COPD from July 1998 to December 1999. The patients were randomized in three groups out of which one group was given pharmaceutical care by pharmacist, one group was PEFR monitoring control group and one was the usual group which did not receive PEFR monitoring or pharmaceutical care. Patients receiving pharmaceutical care had significantly higher peak flow rates than the usual group but showed little benefit compared with peak flow monitoring alone. Patients receiving pharmaceutical care were more satisfied with the healthcare than other two groups. This pharmaceutical care increased the amount of breathing-related medical care sought.9
6.3 / Objectives of the study
1. To assess the patients for existing knowledge of their disease, its complications and requirement of treatment, use of Peak Expiratory Flow Rate (PEFR) in monitoring their disease and contribution of life style to disease by administering standardized asthma QOL questionnaire.
2. To educate the patients about the disease, its complications, compliance, life style modifications with the help of one to one interview and by giving them specially prepared information leaflet.
3. To compare the PEFR/ Pulmonary Function Test (PFT) of patients achieved with education as against those who did not receive the same at regular intervals till the completion of the study.
4. To assess QOL by administering standardized asthma QOL questionnaire at the end of the study once again and to assess impact of patient education.
7.0 / MATERIALS AND METHODS
7.1 / Source of data :
Data will be collected from OPD cards and laboratory reports of patients
Inclusion criteria :
All outpatients diagnosed as asthmatic in the medicine OPD referred by the treating doctors.
Exclusion criteria :
Pediatric patients and Pregnant asthmatic women.
7.2 /
Method of collection of data:
The patients will be randomized into two groups; control and intervention using a chit method. Intervention group will receive comprehensive medication counseling and asthma education at regular intervals while control group will receive routine medical consultation.(1) Pre intervention Studies
The quality of life of patients will be assessed by administering standardized asthma QOL questionnaire.
By one-to-one interview, the levels of self reported adherence to therapy and life style pattern of patients will be assessed.
The patients’ baseline PEFR / PFT will be recorded.
(2) Intervention studies
In this phase, patients will be educated about asthma and its management, its complications, the importance of adhering to medications, life style modifications with the help of one to one interview and by giving them specially prepared information leaflet.
(3) Post-intervention studies
Questionnaire will be re-administered to patients after education (0 month) at 1, 4, 7 months to determine improvement in their QOL.
PEFR / PFT is recorded to check for improvement in asthma and compliance to the treatment.
7.3 / Duration of study
Study will be conducted for the period of 9 months.
7.4 / Does the study require any investigation or intervention to be conducted on patients or other humans?
The study involves one to one interview, talks to patients regarding the disease and importance of adhering to therapy and self management of the disease in preventing complications of asthma attacks and increasing the quality of life.
7.5 / Has ethical clearance been obtained from your institution in case of 7.3?
The protocol will be submitted for ethical committee clearance. Ethical clearance certificate will be submitted to the university as soon as the ethical committee of St. Martha’s Hospital grants it.
8.0 /
References
1. McFadden ER. Asthma. In: Kasper Dennis L, Braunwald Eugene, editors. Harrison’s Principles of Internal Medicine. 16th ed. New York: McGraw-Hill Companies; 2005. vol 1. p. 1508.2. Kelly HW, Sorkness CA. Asthma. In: DiPiro JT, Talbert RL, editors. Pharmacotherapy A Pathophysiologic Approach. 6th ed. New York: McGraw-Hill Companies; 2005. p. 509.
3. Hendeles L, Kelly HW, McRorie T, Self T, Williams D. The role of pharmacist in improving asthma care. National Institute of Health publication [Online]. 1995 July. [cited 2009 Nov 17].
4. Vora A. Asthma: Awareness and Education. JAPI 2009 Aug;57:561.
5. Abdelhamid E, Awad A, Gismallah A. Evaluation of a hospital pharmacy-based pharmaceutical care services for asthma patients. Pharmacy Practice 2008 Jan; 6(1):25-32.
6. Mehuys E, Bortel LV, Bolle LD, Tongelen IV, Annemans L, Remon JP, et al. Effectiveness of pharmacist intervention for asthma control improvement. Eur Respir J 2008;31:790–799.
7. Cordina M, McElnay JC, Hughes CM. Assessment of a community pharmacy-based program for patients with asthma. Available from: URL: http://www.medscape.com/viewarticle/418287
8. Alam K, Palaian S, Mishra P, Sah AK, Upadhyay DK, Bhandari RB. Performance of the medication counselling centre in manipal teaching hospital: A follow up study. Journal of Clinical and Diagnostic Research [serial online] 2009 February [cited 2009 February 2]; 3:1319-1325. Available from: URL: http://www.jcdr.net/back_issues.asp?issn=0973-709x&year=2009 month = February&volume=3&issue=1&page=1319-1325&id=379
9. Weinberge M, Murray MD, Marrero DG, Brewer N, Lykens M, Harris LE, et al. Effectiveness of pharmacist care for patients with reactive airways disease. JAMA 2002;288:1594-1602.
9.0 /
Signature of the candidate
/10.0 /
Remarks of the Guide
/ Recommended for research11.0 /
Name & Guide
Signature
/ Dr. Shobha Rani R.HProfessor and Head
Department of Pharmacy Practice
Al-Ameen College of Pharmacy
Bangalore-560027
12.0 /
Co – Guide
Signature / Dr. Nalini Pais,Additional Medical Superintendent,
St. Martha’s Hospital
Bangalore 560001
13.0 /
Head of the Department
Signature
/Dr. Shobha Rani R.H
Professor and HeadDepartment of Pharmacy Practice
Al-Ameen College of Pharmacy
Bangalore-560027
14.0 /