A research proposal in partial fulfillment for the degree of Masters of Medicine (Paediatrics and Child Health), University of Nairobi.
Dr. Axxxxxxxxx Hxxxx Fxxxx (MBBS)
ABBREVIATIONS
BDI – Beck Depression Inventory
CP – Cerebral Palsy
HRQoL – Health-related Quality of Life
LQoL – Low Quality of Life
KNH – Kenyatta National Hospital
QoL – Quality of Life
SF-36 – 36-Item Short Form Health Survey
WHO – World Health Organization
DEFINITIONS:
Health-related Quality of life: Health-related quality of life (HRQOL) is a multi-dimensional concept that is used to assess the impact of health status on quality of life. The terms Quality of life and Health-related Quality of life are interchangeably used.
Caregiver: A person responsible for the care and wellbeing of children in all contexts.
Primary Caregiver: can be biological parents, children in the family, relatives and house helps (ayahs).
Abstract
Background (too brief)
Providing care to children who suffer from cerebral palsy can have a devastating impact on the quality of life (HRQoL) of their (mothers or) caregivers. The Quality of life of caregivers appears to be influenced in a complex and interrelated way by physical and mental health of the mothers, who provide care, based on the their level of independence, social relationships with which they are established and the environment in which they live and the extent to which they perceive themselves as being burdened by the condition of their children.
Objectives
- To assess the quality of life of primary caregivers (or mothers) of children with cerebral palsy in comparison with primary caregivers or mothers of with healthy children.
- To identify sociodemographic factors that are associated with (low?) quality of life (LQoL) among primary caregivers of children with cerebral palsy.
Methology
An un-matched case –control study design will be employed. Equal number of primary caregivers with children having cerebral palsy will be enrolled as cases and those with healthy children will be enrolled as controls.The quality of life (QoL) will be evaluated using a Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) while functional level of children with celebral palsy will be assessed using Gross Motor Function Classification System. Descriptive statistics will be used to generalize sociodemographic results and quality of life. A cut-off will be used to classify mothers as those with low quality of life and those normal. Multiple logistic regression analysis will be conducted to determine the association between sociodemographic factors and mothers’ quality of life and also compare cases and controls. Odds ratio and 95% confidence intervals will be used to assess the risk factors. Pearson correlation coefficients will used to test the strength of the association. A chi square test will be conducted to establish whether there is any significant difference between the groups.
Chapter one: Introduction and Background
1.0. Background/Introduction
The World Health Organization (WHO) defines quality of life as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns(1). The evaluation of the quality of life has been and continues to be a target of a number of disciplines, including; psychology, nursing, medicine, nutrition, pharmacy, speech therapy and physiotherapy, in which generic instruments and specific instruments of measurement have been used(2).The existence of low health related quality of life among primary caregivers of children with cerebral palsy has a strong evidence in the literature(3-5)and show that caregivers are being affected (6, 7)negatively in various domains. The studies have also revealed that the increase in the burden of cerebral palsy among the children, has a direct link to quality of life of their mothers or caregivers. A study by Halim et al (2013) showed that, sSocial function, mental health, role limitation, emotional status, and vitality in the domain of mental component of (SF-36??) were found to be lower in mothers of children with Cerebral Palsy than in the controls(5). Cerebral palsy being a neurologic non-progressive disorder which permanently affects the body movement, muscle coordination and leading to limitations in activities, affects functional ability of children with cerebral palsy thereby forcing the families of the children to continue providing special care, regular medical checks and physiotherapy treatments. All these(5) negatively affects the quality of life of the family members and in particular the quality of life of the immediate caregivers or mothers(8). In Kenya, various studies have looked at the impact of other conditions such as cerebral malaria and other chronic diseases on the quality of life of the child, however; no comprehensive study has been done to investigate impact of cerebral palsy on the quality of life of the primary caregivers or mothers who nurse these children. According to cerebral palsy society of Kenya, 3 in 100 children are living with celebral palsy and they require full- time care which mostly comes from their mothers(9). Some of the mothers are forced to quit their jobs and assume full responsibility of taking care of these children. Others get sacked from employment due to lack of government protection. All these are likely to affect the psychological and emotional wellbeing of these caregivers or mothers. The end result will be poor health outcomes and/or low quality of life for the mothers. It is against this background that the study seeks to assess quality of life (HRQoL) of primary caregivers having children with cerebral palsy against caregivers who have healthy children and to identify the factors associated with low quality of life among mothers of children with cerebral palsy.
Chapter Two: Literature Review
2.1. Introduction
Taking care of a child with celebral palsy can have very negative effects on the quality of life primary caregivers, thereby compromising their health status. Caregivers will always commit a lot of time and financial resources in providing the needed care to the child and this may have a devastating impact on physical and mental health of caregivers resulting into poor health related quality of life (HRQoL).
2.2. Quality of life of caregivers or mothers of children with a condition of Cerebral palsy
A study conducted by Halim, Y et al (2013) found that mothers who were providing care to children with cerebral palsy had lower quality of life compared to mothers with healthy children. The mean scores were found to be lower on the domains of sSocial function, mental health, role limitation, emotional status, and vitality of mental component of SF-36. BDI scores were also higher in mothers whose children have the condition than controls (5). In relation to mobility of the child, the quality of life was worse in mothers whose children did not move in the area of social functioning in comparison to mothers whose children had the ability to move independently (7). In an integrative literature reviews on the impact of chronic illness of children on caregivers, most studies revealed that the quality of life among caregivers or mothers was being compromised in various health domains(6). In another study looking at the perceived parental stress among caregivers, it was revealed that caregivers of children with chronic illness reported greater parenting stress than caregivers of healthy children(8). In systematic review of literature, most studies reported that there was significant lower quality of life among primary caregivers of children with cerebral palsy than their counter parts with healthy children. The mean scores of the SF-36 subscales were significantly lower in mothers of children with Cerebral Palsy than those in the comparison group(10, 11) and in another study a worse off quality of life was reported by mothers of children with cerebral palsy and their Depression indicator scores were also higher compared to mothers of healthy children(3).
2.3. Predictors of low quality of life in primary caregivers or mothers of children with cerebral palsy
Quality of life (QoL) of parental caregivers has been linked to a poorer child functioning as well as parent mental health concerns across many pediatric conditions. Several predictors of poor Parental Quality of Life consistently emerge such as single parent status; low socioeconomic status, poor family functioning and a lack of social support [6]. Low quality of life of the child was shown to significantly affect quality of life of their mothers or caregivers(12). A child with cerebral palsy and intellectual disability was shown to affect the mothers’ quality of life negatively (OR, 5.4, p <0.00) while having a stable employment had a positive impact on the caregivers’ quality of life (OR. 0.2, p<0.02)(12).Health related and demographic factors were found to affect quality of life of children and caregivers; the increase in disability and presence of complications was shown to decrease the children’ quality of life while the quality of life of caregivers was shown to be affected by the caregivers’ occupation and the degree of the child’s disability (13). Among mothers with Cerebral Palsy children, a negative correlation was detected between the measures of quality of life of SF-36 and mothers’ age, physical function, bodily pain, and physical component scale scores of domains in SF-36(13).
2.4. Conceptual/ theoretical framework
2.4.1. Family Systems and Resource exchange theories
The study will conducted and data analyzed based on two fundamental cognitive theories; the family systems theory (Bowen, 1974) (14), which recognizes the interdependence between family members, oneness of the family and the complex interactions between them and that the wellbeing of each family member depends on others; Resource exchange theory (Foa, 1973)(15) will be used to study family relationships and wellbeing and the resource exchanges that occur in the family interactions. The exchange of resources such as love, services, goods, money and information between family members for whatever reason will result in a gain or a loss of some sort between family members. The decision taken by a mother or a caregiver to provide care services to a chronically ill child or any other member of the family is an expression of love to sick child and in exchange the mother will expect that the child will return the favour in future. Provision of care services by the mother to a child with cerebral palsy involves expenditure of energy and personal time and this will have a negative impact on the quality of life of the mother.
2.4.2. Conceptual Framework
Based on the theoretical framework, explained above, the relationship between quality of life of primary caregivers as a dependent variable ( caregivers’ quality of life) and predictors or independent variables (health related and sociodemographic factors) will be presented using the following conceptual Framework which has been adopted with modification from the conceptual Framework used by Crom et al. (1999) to assess patient-related variables and cancer-related variables on the health status and quality of life of pediatric solid tumor survivors(16).
Independent variables intervening variables dependent variable
Figure 1. Modified Conceptual Framework for the relationship between quality of life of caregivers with CP children and its predictors, Crom (1999).
2.5. Justification of the study
The quality of life of caregivers of children with celebral palsy or any other condition is not always the main focus of healthcare workers during the process of treating these children. The information about the caregiver’s quality of life can provide a better understanding of how, if enough attention is given to these caregivers, they can form an integral part of treatment for any long-term childhood chronic condition. While measures of quality of life have been widely-used in many areas of healthcare practice, the general health of caregivers of children with chronic conditions are rarely assessed. The study findings will be very key to both policy makers as well as health practitioners, in that the knowledge generated through the research will be used to develop strategies and health interventions which can assist individuals and primary caregivers in managing chronic illness such as cerebral palsy in children. To best of my knowledge this is going to be the first study to have examined the quality of life of primary caregivers with children suffering from cerebral palsy in Kenyatta National Hospital.
2.6. Objectives
2. 6.1. Primary Objective
To assess the quality of life of primary caregivers of children with cerebral palsy compared with primary caregivers of healthy children.
2.6.2. Secondary Objectives
To analyze the health and socio-demographic factors associated with the quality of life of primary caregivers (or mothers-delete) of children with cerebral palsy.
Chapter 3: Methodology
3.1. Study design
A concurrently mixed methods research design will be employed. Quantitative data will be collected through a case – control study design in which cases will be collected from mothers of children with cerebral palsy and controls will be the mothers with healthy children. Qualitative data will be collected through focus group discussions and Key Informant Interviews. Need to describe the case control study better.
3.2. Study area description
The study will be conducted at Kenyatta National Hospital. The hospital is one of the largest national referral facilities, situated in the capital city, Nairobi. The hospital has a good number of specialized clinics and therefore receives a large number of patients with different health conditions from a across the country. The study will be conducted among patients visiting Pediatric Neurology, pediatric outpatient and occupational therapy clinics The two clinics have been selected because it is in these clinics that the diagnosis and management of chronic conditions including cerebral palsy are being handled.
3.3. Study population
The study population will be amongst mothers or caregivers who have children aged 2-12 years who visit pediatric neurological and occupation therapy clinics for care or any other child welfare clinic (CHC) within the hospital. The cases will be defined as all (please stick to caregivers only!) mothers or caregivers whose children have been diagnosed with cerebral palsy before the start of the study and have been registered to visit occupational therapy clinics at Kenyatta national hospital. The controls will be all the (mothers or) caregivers who visit the facility for child welfare services but whose children have no cerebral palsy. (which child welfare services???)
Inclusion Criteria
The inclusion criteria for primary caregivers with CP children is to have only one child with CP aged 2-12 years, living with the child and not taking care of another person with chronic illness. Whereas for primary caregivers with healthy children is to have a healthy child in the same age group.
Exclusion Criteria
The exclusion criteria for both groups is not to have any chronic mental or physical disorders. ????define further
3.4. Sample size calculation
The sample size for this was estimated to detect a median change of Quality of Life between primary caregivers or mother of children with CP and primary caregivers of healthy children based on results of a study by Glinac et al 2017(7). The difference in median score for the two groups was 23.53, the inter-quartile range of the quality of life scores was 12.56 and 17.36 for the exposed versus non exposed respectively. Assuming 90% power to detect effect, 5% level of precision, 95% confidence interval, a minimum of 41 mothers would be required in each group. Considering a non –response rate of 20 percent the sample size would be 50 per group, totaling 100 overall.
Sample Size Calculation
The sample size was estimated using the procedures described below (17, 18) for a continuous outcome variable. It was assumed that Quality of life will be measured as scores and based on assumptions of study by Glinac et al 2017(7) which reported median scores and interquartile rate the following formula was adopted
n= (u+v)2(σ12+ σ 02)(r+1)/r
(µ 1- µ 0)2
µ1 – µ0 = Difference between the means/ medians [88.89-65.36]=23.53
σ1, σ0 = Standard deviations of exposed and non-exposed/ exposed [exposed [50.06-77.92]=12.56 vs non exposed [ IQR[79.86-97.22]e=17.36]
u = power = 80%, u is 0.84 (for all cases)
v = Percentage point of normal distribution corresponding to the (two-sided) significance level (95% confidence interval) e.g. if significance level = 5%, v = 1.96
r is the ratio of sample size between the exposed and non-exposed group assume to be 1:1 (r=1)
u =1.28
v = 1.96
σ1 = 17.36
σ0= 27.86
µ1- µ0 = 23.53
11103.17471172
n= (u+v) 2(σ12+ σ 02)
(µ1- µ0)2
n= (0.84 +1.96)2 (17.362 + 27.862) = 10.3041 x [301.3696+776.1796]=
(23.53)2 553.6609
n= (11103.17471172) = 41 minimum sample size per group
553.6609
Assuming an estimated loss to follow-up of 20% of 41, =9)
a total of 50 women will be required per group ( a total of 50 x 2 = 100 mothers ) were required.
3.5. Sampling procedure.
It is estimated that a total of about 100 mothers with CP visit the hospital monthly. In order to achieve the required sample size of 50 mothers with children aged 2 to 12 years with CP, the mothers will recruited sequentially for a total of approximately 2 weeks and maximum of one month in alternate day of the week until the sample size is achieved. The cases will be sampled from the population of caregivers or mothers whose children have been diagnosed with cerebral palsy and the controls will come from the population of caregivers with healthy children. There will be equal number of caregivers per group (50 in each group and a maximum of 100). Mother will be approached randomly as they leave the clinics and those who consent will be interviewed
3.6. Recruitment and consenting procedures
The primary caregivers or mothers will be approached by the research assistants as they leave the clinic, after having been attended to. The research assistant will introduce the study to the participants. The mothers will then be taken through a simple screening process to ascertain their eligibility to participate in the study. The mothers who will have met all the inclusion criteria and accepted to join the study will be taken to a separate room where the consent form shall be read to each one of them individually. The consent form shall be in language that the mother is able to understand comfortably. The mothers shall be free to ask any questions and the research assistant will be obliged to answer or explain to her satisfaction. It will be explained to them that they are free to accept or to decline to participate and refusal to participate will not affect the services they have been receiving from the clinics. The primary caregivers will be recruited into a group after having signed a written consent form. Primary caregivers who do not know how to read and write will sign their consent using their finger mark in the presence of a literate witness who will have been taken through the normal consenting procedure.
3.7. Data collection procedures
3.7.1. Quantitative data collection
Quantitative data will be collected about the general health status of primary caregivers using short form 36 (SF-36). The data about the functional ability of the child will be gotten from the clinical notes or clinical narrative by the physiotherapists. Gross Motor Classification System will then be used to group the children into different categories based on the severity of the condition. A pre-coded individual questionnaire will be administered to each primary caregiver to collect data on their sociodemographic characteristics.
3.7.2. Data collection Tools
3.7.2.1 Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
SF-36 survey form will be used to evaluate the general health of primary caregivers. The form is composed of 36 questions with 8 subscales or domains as physical function, role limitation physical role limitation, emotional, bodily pain, social function, mental health, vitality, and general health. SF-36 survey form is a generic data collection tool which is reliable and has been well validated by a number of studies (1, 19, 20). RAND 36- Item Health survey 1.0 scoring system will be adopted in this study. Each item will be scored on a scale of 0 to 100 in which case 0 and 100 represents the lowest and the highest scores respectively. All the items will be scored such that a higher scores represents a more favorable health condition. Scores of related responses will be averaged to form subscale or domain scores. The overall mean with its standard deviation score will then be computed. Has it been validated locally? Will you do a PILOT study with Kiswahili translations to assess validity?)
3.7.2.2 Gross Motor Functioning Classification System (GMFCS)
Since functional ability of the child affects the emotional wellbeing and hence the quality of life of the caregiver it is imperative that data on the functional mobility should be collected. Gross Motor Functioning Classification System which is a valid and reliable tool(21, 22)has been used to classify cerebral palsy patients based on the severity of the condition on a five-level ordinal scale. The children in level one being least affected and level five being more severely affected and functionally dependent on a support.
3.7.3. Qualitative Data collection
The experiences/perceptions of primary caregivers with cerebral palsy children will be elicited through focus group discussion (FGD). 2 focus groups will be conducted 1 for each for the cases and 1 for the controls. A topic guide and questionnaires will be developed with questions that are relevant to the area of the study. Recorders will be used to tape the conversation during the focus group discussion and the interviews. An experienced moderator will guide the focus group discussions.
3.8. Data Storage and Security
Each questionnaire will be checked to ensure that they do not contain any personal identifiers in order to protect confidentiality of the participants. Any personal identifiers will be removed. The questionnaires will safely be locked in a cabinet that is only accessible to the principal investigator and the research assistants. The recordings of the discussions will be backed on external hard disc and on a password protected laptop which will only be accessible to the principal investigator and the research assistants. The questionnaires will be locked in a cabinet whose key is only accessible to the principal investigator and the research assistants. This will protect the participants of the study and the information obtained from them to ensure confidentiality.
3.9. Data management and analysis
3.9.1. Quantitave data management and analysis
Completed questionnaires will be thoroughly checked for inconsistencies, inaccuracy and missing data. The inconsistent, inaccurate and missing information will be clarified by the research assistants. If not resolved the missing data will be excluded from the analysis. Double data entry will be done in EpiInfo to minimize data entry errors. The statistical analyses will be carried out using STATA v14.0 (StataCorp, College Station, Texas, USA. Descriptive statistics will be used to generalize sociodemographic results and quality of life. Multiple logistic regression analysis will be conducted to determine the association between sociodemographic factors and mothers’ quality of life when the outcome will be classified as low quality of life versus normal. However, when the outcome variable will remain scores and such scores assumed not to be normally distributed, Poisson or negative binomial regression analysis will used to assess the difference in risks of Low quality of life between cases and controls. Pearson correlation coefficients will used to test the strength of the association between continuous variables. A chi square test will be conducted to establish whether there is any significant difference between the groups for categorical variables. The mean scores of subscales of SF- 36 items will computed and presented as ±SD with 95% confidence interval (CI=95%) if the scores will be normally distributed others median and interquartile ranges will be reported .
3.9.2. Qualitative Data Analysis
Qualitative data will be obtained from the FGDs. The data will be analysed manually. First data will be transcribed verbatim. Data obtained in Kiswahili will be translated into English. The phrases or words that defy translation will be reported as excerpts alongside their literal translation. Data cleaning and labelling will be done. All transcripts will then be read and re-read independently by the PI and an experienced qualitative data analyst for familiarization prior to commencing thematic analysis. The coding of excerpts will be done appropriately. An inductive approach to thematic analysis will be used to classify responses into themes that reflect the effect of caregiving on the quality of life of mothers who have children with cerebral palsy. The uniform codes will be put together to produce desired concepts.. Similar concepts will be grouped together to form categories and subcategories will be identified. Linkage will be made among the various categories by identifying the core themes and a story line will be developed. This being a multi-method study the data from the two research paradigms will be integrated.
3.10. Ethical consideration
Ethical approval will be obtained from the Kenyatta National Hospital/University of Nairobi Ethics Review Committee. Participation will be on voluntary basis and the Consent of the recruited primary caregivers will be sought through a written informed consent form. Permission to conduct the research in pediatric neurological and occupational clinics will sought from relevant departmental heads. The consent form will be translated into Kiswahili for parents who do not understand English. It will be explained to the mothers that their participation in the study is voluntary and they are free to leave the study at any time of their choice. That refusal to join the study will not affect the services they have been getting from the clinics or any other department at the hosp
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TIME FRAME
The following is the expected time frame of the study process:
Number Activity Estimated Time
Development of Proposal and presentation Dec 2018 – Jan 2019
Proposal Submission for ethical approval January 2019
Data Collection Febuary 2019
Data Analysis February 2019
Thesis Writing February 2019
Poster Presentation March 2019
Thesis Submission April 2019
STUDY BUDGET
The following is the estimated budget for the study.
Category Remarks Units Unit Cost Total (Ksh.)
Proposal Development Printing drafts 1000 5 5000
Proposal copies 8 1000 8000
Data Collection Stationery pack (Pens, paper etc.) 200 45 9,000
Training research assistants 2 2000 4000
Research Assistants 4 weeks 2000 x 2 4000
Data Entry Data Clerk 1 7500 7500
Data Analysis Statistician 1 45000 45000
Thesis Write up Printing drafts 1000 pages 5 5000
Printing Thesis 10 copies 1500 15000
Contingency fund
Total 102,500