Efficacy of team-based care for distressed patients in secondary prevention of chronic coronary heart disease: a randomized controlled trial

Not Applicable

Conditions: Depressive episode
I20-I25
F54
Other anxiety disorders
Reaction to severe stress, and adjustment disorders
F43
Ischaemic heart diseases
Psychological and behavioural factors associated with disorders or diseases classified elsewhere
F32
F41

Registration Number: DRKS00020824

Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 457

Inclusion Criteria

1. Currently or recently (< 6 months) hospitalized men and women aged 18-85 years with CHD documented by ACS or angiography (=50% stenosis)
2. Persisting psychosocial distress (total score on Hospital Anxiety and Depression Scale [HADS] >12 or score on Perceived Stress Scale [PSS-4] >5) at =2.5 months after iinitial prescreening
3. Insufficient cardiac risk factor control (based on ESC guideline criteria) at =2.5 months after initial prescreening

Exclusion Criteria

1. Acute coronary syndrome or cardiac surgery between prescreening and enrolment
2. Comorbidities with estimated survival <1 year
3. severe mental illness (e.g., acute psychoses, addiction other than tobacco)
4. severe cognitive impairment like dementia or impaired ability to communicate
5. participation in another treatment trial likely to affect the relevant endpoints or interfering with the trial procedures

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment defined as =50% increase in HRQoL (HeartQoL score) from baseline to month 12 (i.e. (score12 months-score baseline)/(42-score baseline)=50%, where 42 is the maximum score).

Secondary Outcome Measures

Name	Time	Method
Change from baseline to month 12 in: (1) continuous HeartQoL score (2) Composite medical risk factor score (systolic blood pressure + LDL cholesterol + HbA1c + smoking status + physical activity); (3) psychosocial status (distress etc.); (4) single elements of composite endpoint; medication adherence, physical exercise, dietary pattern, smoking status, angina symptoms; (5) treatment satisfaction; (6) number of adverse cardiovascular events; (7) HRQoL and variables listed under (1)-(5) until end of follow-up