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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18285541

Enrollment

168

Registered

2016-03-01

Start date

2016-09-21

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026