Evaluation of a patient-centred biopsychosocial blended collaborative care pathway forthe treatment of multi-morbid elderly patients

Not Applicable

Recruiting

Conditions: I50
multimorbiditypsychological comorbidity / distress
Heart failure

Registration Number: DRKS00025120

Lead Sponsor: niveresitätsmedizin Göttingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Patients aged = 65 years
2. Physician-diagnosed chronic heart failure
3. Two or more physician-diagnosed medical comorbidities
4. Elevated psychological distress (HADS total score >12) and/or diagnosed mental disorder(s)

Exclusion Criteria

1. Life expectancy <1 year due to causes other than heart failure
2. Communication barriers (e.g. no telephone, severe hearing impairment, inability to speak, read and understand the language of the country of recruitment)
3. Severe mental disorder needing specific psychiatric treatment and / or interfering with the study treatment, e.g. bipolar disorder, active suicidality, schizophrenia, severe dementia. Current psychosomatic or psychotherapeutic treatment is not an exclusion criterion.
4. Permanently living in a nursing home
5. Being permanently bedridden

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life (HRQoL) measured with the EQ-5D-5L at 3 time points: <br>baseline, 9 months and once between 18 - 30 months, depending on time of <br>enrolment

Secondary Outcome Measures

Name	Time	Method
Objective medical endpoints: admissions to hospitals and nursing homes, morbidity, all-cause mortality. <br>- Cost-effectiveness & cost-utility <br>- Patient- and carer-reported outcomes: depression and anxiety, disease-specific quality of life, cognitive impairment, frailty, activities of daily living, physical function, physical activity, patient expectations to treatment, sleep problems, pain/ discomfort, treatment burden to patients, informal carer burden, emotional support