A study to assess the effectiveness of “Cognitive Training’’ on selected outcome variables among heart failure patients visiting cardiology OPD, Advanced Cardiac Centre, PGIMER, Chandigarh, 2021-23.
- Conditions
- Heart failure, unspecified,
- Registration Number
- CTRI/2022/06/043422
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
All the heart failure patients attending cardiology OPD who met the inclusion criteria will be enrolled in the study.
Using a random number table, participants will be randomized into experimental and control group.
Written informed consent will be obtained from the participants after informing them about the study and the procedure of data collection at the time of enrolment.
At the time of enrolment, baseline information regarding sociodemographic profile, the clinical profile will be obtained and a record analysis of diagnostic test reports, medication card will be done. Along with this baseline assessment of cognitive functions, self-care in heart failure, anxiety, medication adherence, HQOL, functional capacity will be done.
Patients of the experimental group will be provided with cognitive training which includes an educational guidebook in their understandable language containing information about disease condition, heart failure-related cognitive impairment, information cum demonstration on mental and physical exercises to improve cognitive abilities and a video on the dietary pattern, counselling session, meditation audio whereas participants of the control group will continue with routine care.
Telephonic reinforcement will be provided twice a week up to the completion of the study. Cognitive Training Package will be reinforced among the experimental group which includes diet video, meditation audio, physical and mental exercises.
All the participants will be followed up on an OPD basis on the 15th and 30th days after enrolment.
On the 12th week, a posttest to assess cognitive functions (memory, attention/concentration, executive functions), self-care in heart failure, anxiety, medication adherence, HQOL, functional capacity and satisfaction with care provided will be conducted among participants of both the groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 86
1.Chronic Heart failure NYHA class II and III 2.LVEF ≤40 % 3.18-60 years of age 4.MOCA Score <26.
1.Unstable angina 2.Recent MI 3.End stage organ failure 4.ESRD patient on maintenance hemodialysis 5.Mental health disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cognitive functions (memory, attention/concentration; executive functions) Primary outcome will be assessed at baseline and 12 weeks.
- Secondary Outcome Measures
Name Time Method Level of anxiety, self-care in heart failure, health-related quality of life (HQOL), medication adherence, functional capacity and satisfaction level. The secondary outcome will be assessed at baseline and 12 weeks.
Trial Locations
- Locations (1)
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaSuman KumariPrincipal investigator9463244800Sumanbharwal@gmail.com