Cognitive Training Intervention for Heart Failure Patients: A Randomised Controlled Trial

INTRODUCTION

Heart failure (HF) is a significant global public health issue. Since HF affects about 26 million people globally, it has been considered a global pandemic.^[1] According to the global data, India is the country in Southern Asia spending the most on HF, estimating the amount as ~ $1186 million (1.1% of total global HF spending).^[2]

Patients with HF experience a variety of physical and psychological symptoms that limit patients’ daily physical and social activities and lead to poor quality of life (QOL).^[3] Mild cognitive impairment (CI) has been reported in 50–80% of people with HF.^[4] Working memory, learning memory, delay recall, attention, processing speed and executive function are some of the key cognitive areas that are negatively impacted by HF.^[5] Patients might struggle with self-care tasks such as performing activities of daily living, reaching short- and long-term health objectives and adhering to a treatment plan.^[6]

HF population is increasing, but there are no standard guidelines to address their CI leading to unfavourable outcomes. Cognitive training is one such initiative involving interventions where structured activities are planned and performed by patients to enhance their cognitive abilities. Nurse-led cognitive training has shown promising results for improving cognitive functions and reducing the burden on healthcare resources.^[7] In the current Indian scenario, there is a paucity of research studies on the impact of cognitive training interventions among HF patients. Hence, nurses as part of the healthcare workforce can play a significant role in cognitive risk assessment and provide training, thus preventing cognition decline among HF patients, which contributes to improving self-care and QOL.

MATERIALS AND METHODS

A randomised controlled trial to assess the effectiveness of cognitive training was carried out in the cardiology outpatient department of the advanced cardiac centre, Postgraduate Institute of Medical Education and Research, Chandigarh, by enrolling 60 participants using a total enumeration sampling technique.

RESULTS

A total of 60 eligible HF patients were enrolled in the study. At baseline, both the groups were comparable in sociodemographic [Table 1] and clinical profile [Table 2]. The mean age was nearly 50 years in both groups. More than half of the participants in both groups were male. More than 90% of participants were married. More than half of the participants were vegetarians in both groups. Twenty per cent of the control and 43.3% of the experimental participants had a history of previous substance use. Family history of cardiac illness was positive in 20% of the control and 36.7% of the experimental participants [Table 1]. Nearly, 90% of participants in both groups had a history of hospitalisation. The reason for hospitalisation was chest pain in half of the participants followed by shortness of breath. Acute coronary syndrome (ACS) and dilated cardiomyopathy (DCMP) were the two main etiological factors responsible for HF in the present study. Diabetes mellitus (DM) was the most common comorbidity present in participants of both groups. Almost all the study patients received diuretics, Angiotensin - converting enzyme inhibitors / Angiotensin II receptor blockers / Angiotensin receptor-neprilysin inhibitors and beta-blockers. Most of them were on antiplatelet and antihyperlipidemics. Devices such as ICD and CRT were implanted in 6.6% of control and 16.7% of experimental group participants [Table 2].

After the intervention, all parameters of cognitive assessment (memory, executive functions and attention/concentration) showed statistically significant improvement (P < 0.001) among participants of the experimental group which was reflected through significant improvement (P < 0.001) in total MoCA score [Table 3]. After the intervention, significant improvement (P < 0.001) was observed in all self-care domains among participants of the experimental group as compared to the control group [Table 4]. Medication adherence improved significantly (P < 0.001) among participants of experimental group after intervention as mean score increased from 30.28 to 34.83 [Table 5]. Post-intervention all the participants of the experimental group had high medication adherence [Figure 1]. The within-group comparison revealed a significantly high reduction (P < 0.001) in the mean score of physical dimension, emotional dimension and total QOL among experimental group participants after intervention (decreased mean score means a significant improvement in overall QOL and its dimensions) [Table 6]. After the intervention, the mean distance covered in 6MWT significantly increased (P = 0.002) among experimental group participants [Figure 2]. All participants of the experimental group were satisfied with dietary modification and physical exercises. The majority of experimental group participants were satisfied with the medication regimen (96%), cognitive training (89.6%) and stress management and relaxation therapy [Table 7].

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Figure 1:

Level of medication adherence among participants.

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Figure 2:

Comparison of mean distance covered by participants as per 6-min walk test.

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DISCUSSION

In the present study, the mean age of the participants in both the groups was same, that is 50 years. More than half of the participants were male. These findings are congruent with the study conducted by Seth et al. (2015)^[13] where the mean age of

HF patients was 53 years and 63% of participants were male. Some of the study participants had non-vegetarian dietary habits, a history of substance use, a family history of cardiac illness and associated comorbidities (diabetes, hypertension [HTN], coronary artery disease, etc.). These risk factors are strongly linked with heart disease and increase the likelihood of HF. A case-control study revealed similar findings that coronary heart disease, HTN, DM, obesity and smoking are responsible for 52% of HF cases in the population.^[14]

Eighty-three per cent of the control and 90 % of experimental group participants were categorised as NYHA class II HF and few were categorised as NYHA III. Since haemodynamic stability and better functional ability are required to deliver different aspects of cognitive training, NYHA class IV patients were excluded from the study. Cognitive decline is not prominent among HF NYHA class I.

ACS and DCMP were the most common etiological factors of HF among current study participants. It highlights the global burden of ischemic heart disease (IHD) which could lead to cardiac remodelling and eventual progression to HF. These findings are in line with the International Congestive Heart Failure Study (INTER-CHF)^[15] data which shows CAD is the most common aetiology (48%) of HF in Asia and according to Trivandrum Registry^[16] IHDs accounted for 71% of HF. Chest pain was the major reason for previous hospitalisation in almost half of the study participants as myocardial infarction is one of the adverse cardiac events associated with HF. These findings were in line with previous study findings where the most common precipitating factor for hospitalisation in the new-onset HF group was ACS (39.2%) presented with chest pain.^[17]

India is considered the diabetes capital of the world and this has been also reflected in current study findings where DM was the most prevalent co-morbid condition. History of HTN is another comorbidity reported in our study and the majority of the subjects were receiving antihypertensive therapy. Both diabetes and HTN are independent risk factors for HF development. These findings are parallel with the findings of a study conducted by Shukkoor et al. (2021)^[18] that reported type 2 DM as the most prevalent comorbidity (62.8%) in HF patients with reduced ejection fraction followed by HTN (53.3%).

In our study, almost all the patients received diuretics (91.67%), ACEI/ARB/ARNI (88.33%) and beta-blockers (95%). Most of them were on antiplatelets (75%) and antihyperlipidemics (78.33%). A similar trend for drug therapy in HF has been seen in a study conducted by Vellone et al. (2020)^[19] where medications for HF patients comprised ACEI/ARB/ARNI, beta-blocker, MRA, digoxin and diuretics (83.6%), (86.9%), (48%), (10%) and (65%), respectively.

Patients enrolled in our study had MoCA score <26 which reflected initiation of decline in cognition related to HF. A possible reason for cognitive decline in HF patients can be decreased cerebral blood perfusion due to low cardiac output in HF. These findings reflect the need for cognitive training programs to improve the intellectual functions of HF patients for better clinical outcomes. These findings were consistent with the findings of a systematic review which found that patients with HF are at increased risk for cognitive decline over the long-term compared with patients without HF.^[20] Another study conducted by Harkness et al. (2011)^[21] revealed that CI was detected in >70% of HF patients. Early intervention (Cognitive training) at this point can be beneficial in preventing further decline in cognition which, in turn, will contribute toward better self-care, treatment adherence and QOL.

In the present study, experimental group participants received cognitive training for 12 weeks along with routine health care services whereas the control group received only routine care. Based on the present study findings, it can be said that cognitive training is an effective strategy for enhancing cognitive functions among HF patients as statistically significant improvement was noticed in all three dimensions of cognition (memory, executive functions and attention/concentration) as well as in total MoCA score among experimental group participants. The effectiveness of cognitive training has also been reported by Tang et al. (2019)^[22] where MOCA score improved significantly (P = 0.013) in the cognitive training group compared to their counterpart. Similarly, Gary et al. (2019)^[23] reported that participants in the combined aerobic exercise and cognitive training program had significant improvement (P = 0.02) in verbal memory at 3 months and a trend for sustained improvement at 6-months compared to exercise alone or the attention control usual care group. A randomised controlled trial by Pressler et al. (2015)^[24] also showed significant improvement (P = 0.02) in working memory as a result of computerised cognitive training over the 8-week intervention. Working memory as measured by CogState one-back accuracy scores for patients in the brain fitness group improved over time as compared to the control group. CI may impact the ability to perform self-care activities of daily living in HF as self-care is a mentally demanding activity that requires decision-making, disease knowledge and skills in self-management tasks. A systematic review conducted by Lovell et al. (2019)^[25] found that cognitively impaired HF patients tend to display lower levels of self-care as evidenced by low scores on the self-care 64 of the HF Index. After the intervention, a significant improvement was noticed in different self-care domains among experimental group participants. Guidance and counselling related to self-care management in HF might have contributed toward the enhancement of the confidence of participants in carrying out self-care activities. These findings are in line with a previous study by Davis et al. (2012)^[26] where they found that mean scores of all three SCHFI sub-scales showed greater improvement in self-care for the intervention group when compared with the control group.

In general, study participants had high medication adherence levels. Possible reasons for this finding can be life-threatening symptoms as well as prior sensitisation of the participants by the physician about the importance of medication compliance to avoid adverse events. However, a significant proportion of participants had a moderate level of medication adherence which highlights the need for continuous reinforcement for better medication compliance. There was significant improvement in medication adherence among experimental group participants after the intervention. The effect of guidance on the importance of medication adherence was reflected in terms of 100% therapeutic compliance in experimental group participants as compared to their counterparts in which it remained at the pre-intervention level (80%). Daily dairy records of medications consumed may have further improved compliance with treatment regimens. Findings of a systematic review showed a statistically significant improvement in medication adherence in the intervention group which supports the present study findings.^[27]

It was seen that 93.3% of control and 96.7% of experimental group participants had poor QOL at baseline. This may be due to physical and emotional symptoms produced by HF which limit patients’ activities of daily living as well as social interaction ultimately affecting the QOL. The study conducted by Aggelopoulou et al. (2017)^[28] supported these findings and highlighted poor QOL among HF patients (the mean score of MLHFQ was 65.4 ± 20.6). After the intervention experimental group, participants experienced and communicated better QOL and this enhancement in different parameters of QOL can be related to significant improvement in MoCA score, that is cognitive functions and improvement in different domains of self-care (as discussed earlier) made the present study participants in experimental group experience better QOL which has been revealed by study findings. A randomised control trial by Gary et al. (2022) [29] revealed that combined exercise and a computerised cognitive training program resulted in significant improvement (P < 0.039) in QOL among HF patients.

Patients’ satisfaction level reflects the efficacy of health care services of that health institute. The majority of the experimental group participants (89.6%) were satisfied with the cognitive training comprised of an educational guidebook, meditation audio, diet video, and cognitive and physical exercises. Health education, counselling, demonstration and reinforcement are provided for each component as per the content and needs of the patient. On the other hand, just more than half of the control group participants were dissatisfied with the care provided. The findings of the present study were supported by a study carried out by Pressler et al. (2011)^[30] that HF patients had a high level of satisfaction with nurse-enhanced memory intervention and they were interested in improving their cognitive health.

CONCLUSION

Cognitive training is significantly effective in improving cognitive functions (memory, executive functions and attention/concentration), self-care adequacy, medication adherence, QOL and functional capacity among HF patients.