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Grant 2002 (Continued) Number of caregivers in intervention group: 26 Number of caregivers in comparator group A: 22 Number of caregivers in comparator group B: 25 Mean ageof caregivers: 58 ± 12 years % male caregivers: 9% Interventions Title: Social Problem Solving Therapy Partnerships (SPTP) Characteristics: initial 3-hour training provided to family caregivers in the home setting; carers were taught to use a positive problem-solving approach and 4 steps to use when solving problems; this was followed by telephone contacts Intervention provided by: trained nurse Intervention delivered: home and to home by telephone Dose/frequency/timing of intervention: 1 x 3-hour training session prior to stroke survivor being discharged; thereafter, telephone contacts 1 per week for first month, 1 per 2 weeks month 2 and 3 Intervention length: 12 weeks Co-interventions: usual discharge planning services Arm 2: Title: sham intervention Characteristics: telephone contacts asking about health care services stroke survivor had received since the last contact First comparator intervention provided by: graduate research assistant First comparator intervention delivered: to home via telephone Dose/frequency/timing of first comparator intervention: telephone contacts were made 1 per week for first month, 1 per 2 weeks month 2 and 3 First comparator intervention length: 12 weeks Title: control group Characteristics: usual hospital care Second comparator provided by: not applicable Second comparator delivered: not applicable Dose/frequency/timing of second comparator: not applicable Second comparator length: not applicable Outcomes Outcome measures: SF-36; Social Problem-Solving Inventory revised; The Client Satisfaction Questionnaire; CES-D; Caregiver Preparedness; CBS Timing of assessment: 13 weeks after discharge or immediately after intervention finished Notes Numbers of participants have been provided by Professor Joan S Grant by email Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Block or restricted randomisation and choosing blocks at random to create the allocation sequence” Allocation concealment (selection bias) Unclear risk “The person who generated the sequence did not determine eligibility and entry of patients.” Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 22
Grant 2002 (Continued) Blinding (performance bias and detection bias) All outcomes Incomplete outcome data (attrition bias) All outcomes Unclear risk “Yes” Unclear risk “11 participants lost to follow-up at some point during data collection.” 11/ 74 (15%) Reason for missing data reported: yes Missing data balanced between groups: unclear Statistical methods used to deal with missing data: none Judgement: more than 1 outcome of interest in the report is reported incompletely and cannot be entered into the metaanalysis Selective reporting (reporting bias) High risk Selective under-reporting of data Hartke 2003 Methods RCT Participants Source: participants were solicited for information through a review of stroke survivor’s admission records, various media advertisements and news features and targeted community outreach; Chicago, Illinois, USA Definition of caregiver: ’“... Someone who was providing emotional support in addition to participating in care in at least one of the following three areas: personal care, instrumental activities of daily living, decision making or informal case management.” Caregivers’ inclusion criteria: participating in role as caregiver ≥ 1 month; aged ≥ 60 years; be either spouse or partner and living with stroke survivor; not actively participating in caregiver-specific support groups; telephone in the home; sufficient hearing to allow participation in teleconference calls and outcome assessments Caregivers’ exclusion criteria: none stated Stroke survivors’ inclusion criteria: none stated Stroke survivors’ exclusion criteria: none stated Number of caregivers randomised: 124 Number of caregivers in intervention group: 68 Number of caregivers in comparator group: 56 Number of caregivers assessed at final follow-up: 88 Number of caregivers in intervention group: 43 Number of caregivers in comparator group: 45 Mean age of caregivers: unclear % male caregivers: 24% Interventions Title: telephone group intervention Characteristics: psycho-educational support group delivered by telephone and group manual including audiotape of relaxation procedures and a publication on stress management Intervention provided by: clinicians with a psychology, social work or nursing background Intervention delivered: home setting via telephone Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 23
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