Background
Study 1: Cohort Study
Objectives
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Determine prevalence, incidence rate and risk factors of depression in primary care patients with CHD
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Explore and describe the course, relationship, prognosis and current management of physical and depressive symptoms in primary care patients with CHD and co-morbid depression over a four-year period.
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To determine the effect of co-morbid depression on mortality, symptom severity, quality of life, disability, pain, service use (at all levels) and service costs, and lost employment costs in primary care patients with CHD.
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In a subsample, to investigate genetic variation and blood biomarkers that characterise depression in this cohort.
Hypotheses
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That symptoms and disability caused by CHD are associated with depression and that in patients with symptomatic CHD, the severity of symptoms of CHD, is a greater predictor of developing a depressive episode than a past history of depression.
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That patients with CHD and depression use more services for the management of their CHD, are more costly, and have higher lost employment costs than non-depressed primary care patients with CHD.
Methods/design
Study Population
Recruitment of study population
Measures
Measure | Baseline | Follow-up |
---|---|---|
Modified Rose Angina Questionnaire [17] | x | x |
Guy's Hospital Chest Pain Questionnaire [19] | x | x |
Specific Activity Scale[20] | x | x |
General Health Questionnaire-12 (GHQ-12_ [21] | x | |
Hospital Anxiety and Depression Scale (HADS)[22] | x | x |
Clinical Interview Schedule-Revised (CIS-R) [23] | x | |
Patient Health Questionnaire-9 (PGQ-9) [24] | x | x |
EuroQoL (EQ-5D) [25] | x | x |
Medical Outcomes Survey Short Form-12 (SF-12) [18] | x | x |
List of Threatening Experiences Questionnaire [26] | x | x |
Social Problems Questionnaire (SPQ) [27] | x | x |
Client Service Receipt Inventory (CSRI) [28] | x | x |
Brief Illness Perceptions Questionnaire (B-IPQ) [29] | x | x |
Psychological Outcome Profiles Questionnaire (PSYCHLOPS) [30] | x | x |
Rapid Estimate of Adult Literacy in Medicine (REALM) [31] | x |
Inclusion criteria
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Currently registered with GP
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On the coronary heart disease register of participating general practitioners
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Over 18 years of age
Exclusion criterion
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Patients only temporarily registered with participating practices
Sample size calculation
Analysis
Time Scale
Ethical approval
Study 2: A Qualitative Study of patients' perceptions of distress and depression in patients with CHD
Aims
Sample
Method/design
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A description of the participant's current psychological state
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What treatments they think are appropriate for depression/psychological distress?
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How participants may prevent or take protective measures in the context of both CHD and distress/depression
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The views of participants on medication for both their heart condition and depression
Analysis
Developing a scale to differentiate distress and depression
Ethical approval
Study 3: A Qualitative Study of health professionals' perceptions of distress and depression in patients with CHD
Objectives
Method/design
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Observations on the impact of distress and depression on help-seeking in patients with CHD
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Perceptions of the presentation of distress/depression in people with CHD, including patients' beliefs and attributions
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Age, gender, ethnic and cultural differences in the above
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Vulnerability and risk factors for depression in patients with CHD, including social and economic factors
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Current management strategies, including primary and secondary care interventions, patient self-care and non-medical or "life-style" strategies
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Attitudes to various treatment options, including practice-nurse led case-management
Using key findings to inform the development of an intervention
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Findings and recommendations from qualitative studies 2 and 3 will be assessed by an intervention working group, consisting of members of the research team and steering group. These will then inform the content and delivery of the case management intervention.
Patient participation via two focus groups
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A purposive sample of 8-10 qualitative interview participants will be selected to take part in 2 consecutive, focus groups, using the same sample for each group.
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The aim of the first group is to discuss the proposed pilot intervention and elicit suggestions for additions and/or alterations to the proposed content.
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The aim of the second group is to re-present the amended pilot intervention content and to elicit final comments and minor alterations that may be needed.
Ethical approval
Study 4: Feasibility study for a randomised controlled trial of case management for depression in primary care patients with symptomatic coronary heart disease
Objectives
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inclusion/exclusion criteria
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training of staff in the administration and assessment of the intervention.
Method/design
Setting and Practice recruitment
Participant recruitment
Sample size
Inclusion Criteria (Practices)
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Practice keeps a register of patients with CHD for the Quality and Outcomes Framework (QOF) and is willing to liaise over patients in the case management arm when necessary
Inclusion Criteria (Participants)
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Symptomatic CHD as scored on the modified Rose Angina Questionnaire
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A score ≥8 on the depression part of the Hospital Anxiety and Depression Scale
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Aged 16 years or over
Exclusion Criteria (Participants)
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Temporary registrations
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Actively suicidal patients
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Psychotic depression as evidenced by delusions and/or hallucinations
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Non-English speaking
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Participants currently in hospital for treatment of their CHD
Intervention
Control
Measures
Outcome Parameter | Instruments |
---|---|
Primary Outcome
| |
Depression | Hospital Anxiety and Depression Scale[22] |
Secondary Outcome
| |
Depression | Patient Health Questionnaire-9 [24] |
Coronary Heart Disease | |
Quality of Life | |
Adherence to medication | Adapted version of Morisky adherence questionnaire[35] |
Life events | List of Threatening Events Questionnaire [26] |
Social problems | Social Problems Questionnaire [27] |
Health Service Utilisation | Client Service Receipt Inventory (CSRI) [28] |
Illness Perceptions | Brief Illness Perceptions Questionnaire [29] |
Wellbeing | Warwick-Edinburgh Mental Well-being Scale [36] |
Participants problem priorities | PSYCHLOPS [37] |