Investigator(s)
| WHO Technical Officer |
Ravivarman LAKSHMANASAMY World Health Organisation Country Office India Ravivarman LAKSHMANASAMY 
|
| Principal Investigator |
Ashima Nehra All India Institute of Medical Sciences (AIIMS), New Delhi, India - 110029 Ashima Nehra
|
Title(s) and abstract
| Scientific title | To develop and ascertain efficacy of Indian Neuropsychological continuum of healthcare model for stroke survivors and caregivers: A Randomized Control Trial |
| Public title | Effect of Neuropsychological support in stroke survivors |
| Background | Stroke demands serious attention towards prevention and treatment in developing countries. Stroke related burden is likely to exacerbate in future thus making it a major health, economic, social burden in low and middle economic countries like India. Despite stroke guidelines recommending the provision of long-term support, most survivors do not receive regular ongoing support following hospital discharge. A high proportion of survivors are left with disability without sufficient access to rehabilitation. An integration of psychological, socio-cultural and spiritual aspects of counselling along with the biomedical model of treatment to accept a diverse range of patient narratives along with a broad approach to health and healing is much needed. Therefore, this study attempts to determine the efficacy of a healthcare model specifically developed to improve quality of life and change in cognitive level in stroke patients by means of a trial. |
| Objectives | General objectives: 1. To determine the efficacy of the Indian neuropsychological continuum of healthcare model (CoC) to improve the QoL of Stroke survivors post intervention through RCT 2. To determine the efficacy of the Karmic cognitive model to reframe patients’ fatalistic Karmic beliefs (having a pre-defined destiny towards Free will to engaging patients in positive treatment-congruent current actions for better future outcomes. Specific objectives: 1. To determine the effect of the PIN-CoC Model on the Quality of Life (QoL) of Stroke Survivors1 month and 3 months post intervention. 2. To determine the effect of the PIN-CoC Model on the cognitive decline of Stroke Survivors 1 month and 3 months post intervention. 3. To assess the effectiveness of developed rehabilitation model on patients’ self-efficacy and health related locus of control |
| Study Methods | Study design: Single-blinded Randomized Controlled Trial (RCT) with an ABA design (pre-intervention-post)i.e. patients will be assessed at baseline, immediately after intervention, 1 month and 3 months post intervention. After baseline assessment, the developed Intervention will be provided over a period of 14 days. Patients will be randomized using computer generated random sequence allocation. The sample will be randomly allocated into an intervention group (IG) and Treatment as per usual group (TAU). The assessments will be done by two investigators. The outcome post-assessor would be blinded in this study. Study setting will be Neuropsychology, Neurosciences Centre, All India Institute of Medical Sciences (AIIMS), New Delhi, India. Study population will be stroke patients with specified inclusion criteria. Sample size- By the use of prediction method as suggested by the expert reviewer and the institute biostatistics department, the required sample size per group is 22. Sampling method- Consecutive random sampling Data collection- Post recruitment based on Inclusion criteria, basic demographics of the patients will be collected i.e. age, gender, BMI, medical history, psychiatric history. Post this a baseline assessment will be performed (which will be repeated at two time points post the intervention) Data management plan- Quality of the study will be ensured with the following in addition to following the CONSORT guidelines- Randomisation: Based on computer generated random sequence allocation Allocation: Random allocated into intervention group (IG) and Treatment as per usual group (TAU) Concealment: The allocation will be concealed in a sealed envelope and shall be opened only after patient consent for randomization Coding of each patient with a unique id |
| Expected outcomes and use of results | Primary Outcome – Quality of Life Secondary outcome – Prevention of cognitive, psychological decline; change in Karmic belief, heath related Locus of Control |
| Keywords | Stroke survivors, Randomized control trial, Neuropsychological care |
Research Details
| Student research | No |
| Start Date | 01-Nov-2022 |
| End Date | 30-Nov-2023 |
| Key Implementing Institution | All India Institute of Medical Sciences, New Delhi |
| Multi-country research | No |
| Nationwide research | No |
| India | |
| Research Domain(s) | Non-communicable diseases & Healthy Lifestyles |
| Research field(s) | Non-communicable Disease |
| Involves human subjects | Yes |
| Clinical Trial with Human Subjects | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Final decision available |