| CTRI Number |
CTRI/2024/06/069619 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How independent the patient with Parkinsons is in his daily functioning and does this affect the quality of life of their caregiver |
|
Scientific Title of Study
|
Correlation between functional independence of Parkinsons patient and Quality of life of caregiver |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VAZ SHERWIN RYAN |
| Designation |
Post Graduate Student |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Neuro Physiotherapy Father Muller College of Physiotherapy
North Goa
GOA
403005
India |
| Phone |
8788115753 |
| Fax |
|
| Email |
sherwinvaz46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SYDNEY ROSHAN REBELLO |
| Designation |
PROFESSOR |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
Department of Neuro Physiotherapy Father Muller College of Physiotherapy
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9343569219 |
| Fax |
|
| Email |
sydnypt@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
VAZ SHERWN RYAN |
| Designation |
Post Graduate Student |
| Affiliation |
father muller medical college |
| Address |
Department of Neuro Physiotherapy Father Muller College of Physiotherapy
North Goa
GOA
403005
India |
| Phone |
8788115753 |
| Fax |
|
| Email |
sherwinvaz46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neuro Physiotherapy Father Muller Medical College and Hospital Kankanady Mangalore karnataka 575002 India |
|
|
Primary Sponsor
|
| Name |
VAZ SHERWIN RYAN |
| Address |
Father muller college of Physiotherapy kankanady Mangalore dakshina karnataka india 575002 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSherwin vaz |
Father Muller Medical college & Hospital |
Father Muller College Of Physiotherapy, department of Neuro Physiotherapy
Dakshina Kannada
KARNATAKA |
8788115753
sherwinvaz46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Medically diagnosed cases of Parkinson’s Disease
Caregiver should be more than 18 years of age
Caregiver should be able to read in English or Kannada
Caregiver should spend at least 6 hours with the patient
|
|
| ExclusionCriteria |
| Details |
Any neurological conditions affecting functional independence of patient other than Parkinson’s Disease.
Absence of a clearly identified caregiver
Any handicap/disability in the caregiver
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| functional independence of Parkinsons patient using the - Barthel Index |
once during the study at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life Of The Caregiver will be assessed using The - WHOQOL-BREF questionnaire |
Once during the study when the caregiver arrives with the patient at baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A neurodegenerative disease that progresses over time, Parkinsons disease is characterized by “motor and non-motor manifestations†that affect “Activities of daily living†(ADLs) and Quality of life (Qol) [1]. A caregiver who can help the patient with (ADLs) will be necessary due to the increased impairment and symptoms [2]. An essential role is played by the Caregivers of the Patients with Parkinsons (Pwp) in assisting and aiding in (ADLs), such as washing, dressing, toileting and feeding [3]. By avoiding or at least delaying the onset of complications of Parkinson’s, the caregivers of the Pwp play a prominent role in avoiding and minimalizing the institutionalization of Pwp thereby enabling them to stay within their communities for longer durations fulfilling a key wish for many people with Parkinsons [4].In a study comprising 198 individuals diagnosed with (PD), almost all of them exhibited a decrease in their capacity to carry out (ADLs) over a period of 10 years [5], For those with PD, having a caregiver has been shown to result in fewer unmet requirements, improved medication and treatment adherence, and overall higher-quality care [6].Research and studies have shown correlations between carer stress and care recipient quality of life (QoL), with higher carer strain being linked to lower QoL[7]. The increasing dependency of patients as Parkinson’s Disease progresses, will alter caregivers’ quality of life (QOL) across the continuum of care [8].The decision to institutionalize patients is influenced by the caregiving capabilities of the caregivers. Typically, the caregivers only consider institutionalization when they feel unable to cope with the physical, emotional, or financial demands of caregiving. Additionally, the stress of caring for Pwp can significantly impact caregivers’ mental and physical well-being, leading to adverse consequences [9].Elevated caregiver burden not only impacts the Qol of caregivers but also diminishes the Caliber of care and assistance provided for Pwp, resulting in negative outcomes for them. This initiates a detrimental cycle wherein the deterioration in care quality worsens the activities of daily living performed by PD patients, perpetuating a cycle of burden and reduced well-being for both caregivers and patients [10].Early identification of stress factors in caregivers is essential for preventing long-term burden, particularly when a patient’s Parkinsonism-related disability is the main contributor. This timely recognition can offer valuable understanding of the caregiving role, ultimately enhancing patient care [11]. Therefore, it’s essential to develop a better and thorough understanding of the determinants that influence the QOL of caregivers and their burden This understanding is vital for developing specific interventions aimed at supporting caregivers of Pwp [12].Hence there’s a need to analyze the Quality of life of caregivers with functional independence of Parkinson’s patients. The ethical clearance for this study will be obtained from the ethics committee of Father Muller Medical College. Written informed consent will be obtained from the patients/caregivers/family members after which they will be explained the details of the study procedure. Parkinson’s patients and their caregivers will be screened according to the inclusion and exclusion criteria. The basic parameters along with the patients MD-UPDRS scores will be noted. The Parkinsons patient will be marked on the Barthel index for functional independence and the caregiver will be administered the WHOQOL-BREF questionnaire to assess the quality of life. The data will be collected in the respective data collection forms. Both the instruments will be administered on the same day. As the illness advances, the patient’s motor impairment worsens, resulting in greater reliance on the caregiver for daily tasks. This heightened dependence amplifies the burden on the caregiver, detrimentally affecting the quality of care provided to the patient. Early recognition of stress-inducing factors in caregivers can prevent its prolonged presence, offering deeper understanding of the caregiving role and ultimately improving patient care.
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