A Study of Emotional and Mental Effects in Caregivers of Children with Childhood Onset Gaucher Disease

Not yet recruiting

• Conditions: Caregivers of Children with Childhood onset Gaucher Disease.

• Registration Number: CTRI/2021/08/036053
• Lead Sponsor: Seth GS Medical College and KEM Hospital

Brief Summary

**SUMMARY**

**Introduction:**

Chronicillness like GD carries the potential to impact on the life of the family. Lifelongtreatment and complications of GD could affect emotional functioning, dailyactivities, family experiences and occupational capabilities of patients andtheir caregivers. Though treatment (enzyme replacement therapy or substratereduction therapy) ameliorates several debilitating symptoms of GD and improveslifespan, psychosocial and financial impact of a chronic disease on childrenand family is a continuous lifelong possibility. The caregivers are directlyinvolved in long-term treatments, coordination of health services delivery, andmanagement of the social, financial, and emotional challenges that accompanychronic diseases and these activities have physical, psychological, andeconomic repercussions for family caregivers . There are no studies on impactof GD on emotional health of caregivers. The present study is thereforeconceptualized to explore the psychological impact (Depression, Anxiety andStress) of a lifelong genetic disease on caregivers of persons with GD.

 Objectives:Our aim is todetermine whether there is an adverse psychological impact (stress, anxiety ordepression) in caregivers of patients with childhood onset Gaucher disease andto study factors contributing to this burden.Methodology:It will be a Single Centric, prospective, observational study to beconducted in the Pediatrics wards/Genetic clinic of K.E.M.H. over 18 months(May 2021-October 2022), after approval by IEC. It will be a conveniencesampling and sample size of 60 is expected. The participants will be enrolledaccording to inclusion criteria. They shall be explained about the study andwritten, informed consent shall be obtained. An interview shall be conductedwith the help of a questionnaire and the case record form shall be filledaccordingly.

·  Section 1- Child’s demographicdata as well as data about disease and treatment related parameters.

·  Section 2- Parents’demographic data including socioeconomic Status of the Family.

· Section 3- Data about Psychological assessment in the form oftwo sets of questionnaire .This section will be given to the participants tochoose the most appropriate responses from the given choices.

ANALYSIS:This is aobservational type of study. Demographic data will be analysed usingdescriptive tests like mean, median and mode.The data obtained from questionnaire will beassessed in the form of a scoring system.

Correlationstudies between demographic / non demographic variables with DASS and CSI-SFscores. Pearson’s product-moment correlation coefficient (r) will be used toinvestigate the associations between anxiety and the psychosocial,sociodemographic, and clinical variables (potential predictors).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-09
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Consenting parents of patients 1.
• With a confirmed diagnosis of Gaucher disease (enzyme activity ± molecular study) in childhood, 2.
• On treatment for Gaucher disease (Enzyme replacement therapy or Substrate Reduction Therapy) for at least one year or treatment naïve Gaucher disease.

Exclusion Criteria

• Parents with a chronic disease or those caring for another family member with a chronic disease 2.
• Parents with a background of psychiatric illness or addictions (e.g. alcoholism).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study would help in identifying the parental stressors associated with the patients of GD and thus in turn will help to develop strategies to effectively manage them on time.	Data collection- September 2021 to August 2022 | Data Analysis- August 2022 to October 2022 | Manuscript Writing- November to December 2022

Secondary Outcome Measures

Name	Time	Method
Study will help to develop strategies to effectively manage identified parental stressors on time.

Trial Locations

Locations (1)

Seth GS Medical College and KEM Hospital, Parel, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Seth GS Medical College and KEM Hospital, Parel, Mumbai

🇮🇳Mumbai, MAHARASHTRA, India

Dr Mamta Muranjan

Principal investigator

02224107645

muranjanmamta@rediffmail.com