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

Completed

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

• Registration Number: ISRCTN18285541
• Lead Sponsor: Hospital of Caceres (Complejo Hospitalario de Cáceres)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-01
• Last Update Posted: 30 April 2018
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>

Secondary Outcome Measures

Name	Time	Method
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<br>2. Adherence to treatment, assessed via interview and Morisky-Green test score at baseline and 6 months <br>3. Change during the study in control of neuropsychiatric symptoms, assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q) scores at baseline and 6 months<br>4. The effect of the DMP on caregiver burden, estimated as the change in the Caregiver Burden Interview during the study<br>5. Cost analysis, assessed via the difference between groups in sanitary system direct costs