Background
Methods
Study design, setting and participants
Randomization and blinding
Intervention
Usual care
Effect outcomes
Cost outcomes
Cost category | Unit | Unit cost | Caregivers | Patients |
---|---|---|---|---|
(€, 2009) | (n = 125) | (n = 118) | ||
Mean (SD) | Mean (SD) | |||
Ambulatory care (except home care) | ||||
General practitioner | Contact | 28a
| 5.0 (4.3) | 4.9 (5.4) |
Paramedical therapist | Contact | Variableb
| 7.3 (14.3) | 10.2 (19.9) |
Psychologist or psychotherapist | Contact | 80 or 77 | 0.5 (2.7) | 0.2 (0.7) |
Social worker | Contact | 65 | 0.2 (1.0) | 0.4 (2.0) |
Social psychiatric nurse | Contact | 45 | 1.7 (3.3) | 1.8 (3.6) |
Psychiatrist | Contact | 171 | 0.03 (0.4) | 0.2 (0.7) |
Other counsellorc
| Contact | Variable | 0.3 (1.5) | n/a |
Peer support group counselling | Session | 68 | 1.8 (3.8) | 0.1 (0.7) |
Outpatient appointment | Contact | 72 | 2.6 (3.0) | 3.9 (3.8) |
Home care and other support | ||||
Domestic home help | Hour | 24 | 10.6 (17.5) | see caregiver |
Professional home care | Hour | 44 | 0.5 (4.2) | 5.4 (15.8) |
Respite care | Hour | 12.50 | 1.6 (8.3) | n/a |
Meal supply at home | Meal | 6 | 2.7 (20.6) | 3.4 (22.8) |
Day treatment and admissions | ||||
Day treatment | Day | 251 | 1.6 (8.2) | 48.3 (67.2) |
Admission, elderly home | Day | 90 | 0.2 (2.3) | 1.1 (7.6) |
Admission, nursing home | Day | 238 | 0.4 (3.8) | 15.2 (46.1) |
Admission, academic hospital | Day | 575 | 0.2 (2.0) | 0.3 (1.8) |
Admission, non-academic hospital | Day | 435 | 0.4 (1.9) | 1.0 (5.5) |
Admission, intensive care unit | Day | 2183 | 0.02 (0.2) | none |
Absenteeism | ||||
Paid labour | Day | Friction costsd
| 2.2 (11.7) | n/a |
Unpaid labour | Hour | 12.50 | 4.7 (20.7) | n/a |
Informal care | Hour | 12.50 | see patient | 3760.3 (3273.0) |
Power calculation
Statistical analysis
Results
Participant flow and recruitment
Baseline characteristics
Caregiver | Patient | |||
---|---|---|---|---|
Intervention (n = 96) | Usual care (n = 96) | Intervention (n = 96) | Usual care (n = 96) | |
Age, M (SD) | 67.8 (9.8)* | 71.2 (10.7) | 72.8 (9.1)* | 76.7 (8.3) |
Female gender, n (%) | 67 (69.8) | 68 (70.8) | 30 (31.3) | 32 (33.3) |
Spouse of the patient, n (%) | 92 (95.8) | 89 (92.7) | ||
Living with patient, n (%) | 93 (96.9) | 91 (94.8) | ||
Educational level, n (%) | ||||
Elementary/Lower | 28 (29.2) | 34 (35.4) | 42 (43.8) | 44 (45.8) |
Secondary | 37 (38.5) | 30 (31.3) | 30 (31.3) | 28 (29.2) |
Higher/ University | 29 (30.2) | 32 (33.3) | 24 (25.0) | 22 (22.9) |
Utility score SF6D, M (SD) | 0.8 (0.01) | 0.7 (0.01) | 0.7 (0.01) | 0.7 (0.01) |
Anxiety score HADS-A (0–21), M (SD) | 6.1 (3.4)* | 4.8 (3.5) | ||
Depression score CES-D (0–60), M (SD) | 12.1 (7.9) | 10.8 (7.1) | ||
ADL independencies (out of 6), M (SD) | 5.1 (1.4) | 5.3 (1.1) | ||
IADL independencies (out of 7), M (SD) | 2.7 (1.8) | 2.6 (1.5) | ||
MMSE (0–30), M (SD) | 21.4 (4.9) | 21.7 (5.6) |
Numbers analysed
Uptake of the intervention
Costs
Cost category | Intervention (n = 96) | Usual care (n = 96) | Unadjusted difference | 95% CI*
| Adjusted difference**
| 95% CI*
|
---|---|---|---|---|---|---|
M (SD) | M (SD) | |||||
Caregiver
| ||||||
Ambulatory care | 842 (103) | 1,110 (124) | -268 | -571; 20 | -335 | -663; -28
***
|
Day treatment and admissions | 854 (454) | 1,074 (436) | -220 | -1371; 1081 | -107 | -1327; 1272 |
Home care and other support | 751 (171) | 1,253 (247) | -502 | -1151; 7 | -438 | -1015; 57 |
Absenteeism | 1,133 (640) | 691 (458) | 442 | -742; 2058 | 57 | -1366; 1436 |
Medication | 271 (48) | 389 (57) | -118 | -266; 19 | -94 | -259; 48 |
Intervention | 129 (10) | 0 | 129 | 110; 147
***
| 129 | 109; 149
***
|
Total caregiver | 3,979 (884) | 4,517 (876) | -538 | -2976; 1681 | -788 | -3529; 1439 |
Patient
| ||||||
Ambulatory care | 1,057 (115) | 1,016 (126) | 41 | -274; 328 | -81 | -438; 221 |
Day treatment and admissions | 18,388 (2639) | 17,124 (2735) | 1264 | -6122; 8436 | 1208 | -6017; 8620 |
Home care and other support | 1,451 (425) | 1,581 (482) | -130 | -1362; 1121 | -109 | -1439; 1177 |
Medication | 1,097 (131) | 1,106 (102) | -9 | -284; 308 | -98 | -374; 182 |
Informal care | 51,860 (4585) | 49,858 (4065) | 2002 | -10082; 13877 | 4017 | -8541; 16715 |
Total patient | 73,854 (6106) | 70,684 (5706) | 3170 | -13398; 19776 | 4936 | -11808; 21750 |
Total patient- caregiver dyad
| 77,832 (6384) | 75,201 (5997) | 2631 | -14520; 20118 | 4149 | -13371; 21956 |
Effects
Analysis | Outcome | N | ∆ effects | 95% CI | ∆ costs | 95% CI#
| ICER | Distribution cost-effectiveness plane (%) | |||
---|---|---|---|---|---|---|---|---|---|---|---|
NE | SE | SW | NW | ||||||||
ITT Unadjusted | Patient-caregiver dyad QALY | 192 | 0.006 | -0.05; 0.06 | 2631 | -14520; 201118 | 438299 | 31 | 27 | 12 | 30 |
Caregiver QALY | 192 | 0.004 | -0.04; 0.04 | -538 | -2976; 1681 | -149984 | 15 | 43 | 25 | 17 | |
Patient QALY | 192 | 0.002 | -0.04; 0.04 | 3169 | -13398; 19776 | 1313110 | 31 | 25 | 11 | 33 | |
Caregiver incidence of depression and/or anxiety (MINI)* | 192 | -0.04 | -0.20; 0.11 | -538 | -2976; 1681 | 12604 | 8 | 21 | 47 | 24 | |
ITT Adjusted | Patient-caregiver dyad QALY | 192 | 0.04 | -0.03; 0.08 | 4149 | -13483; 21965 | 157534 | 54 | 30 | 3 | 13 |
Caregiver QALY | 192 | 0.02 | -0.005; 0.05 | -788 | -3551; 1453 | -32254 | 24 | 71 | 3 | 2 | |
Patient QALY | 192 | 0.002 | -0.03; 0.04 | 4936 | -11631; 22073 | 2574938 | 35 | 19 | 9 | 37 | |
Caregiver incidence of depression and/or anxiety (MINI)* | 192 | 0.01 | -0.14; 0.17 | -788 | -3566; 1399 | -59011 | 14 | 44 | 31 | 12 | |
CCA | Patient-caregiver dyad QALY | 101 | -0.005 | -0.08; 0.07 | 3951 | -17662; 25955 | -807703 | 23 | 20 | 16 | 40 |
Caregiver QALY | 119 | 0.02 | -0.02; 0.05 | -483 | -2514; 1720 | -24472 | 25 | 62 | 6 | 8 | |
Patient QALY | 102 | -0.02 | -0.07; 0.03 | 4373 | -16422; 25402 | -240247 | 12 | 12 | 22 | 54 | |
Caregiver incidence of depression and/or anxiety (MINI)* | 106 | 0.08 | -0.06; 0.21 | -711 | -2783; 1775 | -9271 | 20 | 68 | 9 | 4 |