Effect of a dual intervention in elderly heart failure patients with cognitive impairment and their caregivers after hospital discharge: a randomized controlled trial

• Register: ISRCTN
• Last refreshed on: 30 April 2018
• Main ID: ISRCTN18285541
• Date of registration: 01/03/2016
• Prospective Registration: Yes
• Primary sponsor: Hospital of Caceres (Complejo Hospitalario de Cáceres)
• Public title: Effect of a dual intervention in elderly heart failure patients with cognitive impairment and their caregivers after hospital discharge: a randomized controlled trial
• Scientific title: Effect of a disease management program in elderly heart failure patients with cognitive impairment after a hospital discharge, through a dual intervention in patients and caregivers and its follow-up by a multidisciplinary team, delivered by geriatric day-hospital vs. usual care
• Date of first enrolment: 21/09/2016
• Target sample size: 168
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN18285541
• Study type: Interventional
• Study design: Single center single-blind randomized controlled study (Treatment)

Countries of recruitment

Spain

Contacts

• Name: José Luis González Guerrero

Key inclusion & exclusion criteria

Inclusion criteria: Consecutive patients diagnosed with acute HF and discharged from the Geriatric Service of the Cáceres Hospital Complex (Spain) are included. The patients are diagnosed according to the criteria of the European Society of Cardiology and must have:
1. A hospital stay of more than 2 days
2. A responsible caregiver

After inclusion and exclusion criteria are reviewed, patients/caregivers will be asked if they would be willing to take a cognitive screening test and potentially participate in the study. If cognitive impairment is present they will be included in the study after patients and caregivers to sign informed consent.

Exclusion criteria: 1. Terminal patients (with an expected survival of less than 6 months)
2. Bedridden patients
3. Patients with severe dementia (Global Deterioration Scale grade 7) or other serious psychiatric disease
4. Patients who were impossible to follow up
5. Patients in retirement homes
6. Patients or caregivers who refused to participate

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Heart failure; Disease management programs; Elderly patients; Cognitive Impairment.
Circulatory System

Intervention(s)

Intervention group: The disease management program (DMP) has four main components:
1. Educational intervention on management of heart failure (HF) to improve patient and caregiver's knowledge of the disease and management skills
2. Monitoring and improvement of therapy according to international guidelines
3. Monitoring of clinical, functional, neuropsychological status and comorbidity of the patient
4. Monitoring of caregiver burden and social network

The intervention program consists of two phases:
1. First phase: prior to discharge the DMP multidisciplinary team, consisting of a geriatrician (case manager), a nurse and a social worker assesses and has an in-depth interview with the patients and their caregivers. Later the patients and their caregivers receive formal education session about the disease using an information manual explaining details regarding the disease, such as diet, weight control, exercise, lifestyle, and medication, as well as how to recognize cardiac decompensation symptoms, following the guidelines of de ESC. The educational session is adapted to the degree of cognitive impairment (CI) of the patient and it is focused in the caregiver. In addition, the case manager provides information to the caregiver about the process of CI, their symptoms and their management. As support material they will be given an informative manual on HF and manual control recommendations of psychological and behavioral symptoms related to CI.
2. Second phase: regular follow-up is scheduled. Nurse contact each patient, via telephone, 48 hours after the hospital discharge, to record any problems. After 10 days, the team examines the patients/caregivers in the geriatric day care hospital (GDCH), using educational reinforcements and evaluating for possible cardiac decompensation.
The subsequent follow-ups occur at the GDCH, 1 and 3 months after the hospital discharge. During these programmed sessions, the team assesses the patients/caregivers for treatment complian

Primary Outcome(s)

Event-free survival, defined as the time elapsed until the first readmission or until death of the patient for any cause during the study period. The hospital readmissions (total and HF-related) and mortality (total or HF-related) are accounted for. For event-free patients, the data were censored on the last day of the study. The event-free variable is tested using the Kaplan-Meier survival curve and the log-rank test. A sequential survival analysis is performed, using the Cox model, to determine if the treatment of the patients is an independent event predictor after adjustment for other relevant covariables.

Secondary Outcome(s)

1. Caregiver's knowledge of the disease (HF) and management skills, using a 15-question scale developed by DeWalt et al (Patient Education and Counseling 55 (2004) 78–86) and management skills, assessed using the European Heart Failure Self-care Behaviour Scale (EHFScBS). Scales scores at baseline and 6 months will be calculated for each group in the trial estimating the effect of the DMP as the difference between groups
2. Adherence to treatment, assessed via interview and Morisky-Green test score at baseline and 6 months
3. Change during the study in control of neuropsychiatric symptoms, assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q) scores at baseline and 6 months
4. The effect of the DMP on caregiver burden, estimated as the change in the Caregiver Burden Interview during the study
5. Cost analysis, assessed via the difference between groups in sanitary system direct costs

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Ethics Committee for Provincial Clinical Research, 24/02/2016.

Results

• Results available: Yes
• Date Completed: 01/03/2019