Goldberg 1997.
Study characteristics | ||
Methods | Study design: parallel design Number arms: 2 Treatment arm: home‐based therapeutic intervention Control arm: usual care |
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Participants | Geographical location: USA
Setting: inpatient
Stroke criteria: unclear. Method of stroke diagnosis: unclear. Time since stroke: on average 2 weeks (treatment group) and 13 weeks (control group) prior to randomisation Inclusion criteria: 1) home to return to and readily identified primary caregiver Exclusion criteria: 1) severe pre‐morbid or co‐morbid conditions sufficient to impact significantly on their capacity to recover from the stroke; 2) residual cognitive or communicative impairment prevent participation in interviews Total number randomised in this study: 55 Number randomised to treatment group: 27 (48% men, median age 72 years, range 65 to 84 years) Number randomised to control group: 28 (55% men, median age 72 years, range 65 to 81 years) Total number included in final analysis: 41 Number included in treatment group for final analysis: 21 Number included in control group for final analysis: 20 |
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Interventions | Treatment: weekly phone contact, monthly home visits; home‐based therapeutic team attend specifically to psychosocial stressors and prevent significant psychosocial problems from accelerating Treatment duration: treatment continued for 1 year Administered by: multidisciplinary team included a psychiatrist, psychologist, recreational therapist, research programme case manager, social worker Supervision: case manager (social worker) Intervention fidelity: not reported Control: usual care, no visits Follow‐up: last follow‐up at 1 year (end of treatment) |
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Outcomes | Primary outcomes
Secondary outcomes
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "... subjects were randomized using a random number table to either the experimental group, which received the STAIR program, or to a control group, which did not." pp. 67 |
Allocation concealment (selection bias) | Unclear risk | Comments: method of allocation not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "... since the subjects clearly could not be blinded to their own treatment." pp. 67 |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Blinding of the data collector was attempted, although this was difficult to consistently accomplish and maintain, since the subjects clearly could not be blinded to their own treatment." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comments: per protocol analysis reported only. 14/55 participants were not included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Comments: no trial protocol available to compare with the publication |
Other bias | Low risk | Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics |