Teri 2003.
Methods | Randomised controlled trial. Study duration: 24 months. | |
Participants | 153 community dwelling care recipients (CR) meeting criteria for Alzheimer’s disease and their caregiver (CG). CRs had a mean age of 78 years, with an average MMSE score of 16.8 and were predominantly male. CGs had a mean age of 70, and were predominantly female. | |
Interventions | Caregiver training in behavioural management techniques with home‐based exercise program ‐ Reducing Disability in Alzheimers disease (RDAD) Control (routine medical care) Primary aim of intervention: CG management of CR problem behaviours and decreasing CR frailty and behavioural impairment. (See Table 2) |
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Outcomes | Physical Health and Function (SF36) Affective Status ‐ Hamilton Depression Rating Scale (HDRS) & Cornell Scale for Depression in Dementia CR Physical Health & Function Revised Memory and Behaviour Problem Checklist (RMBPC) (See Table 3) |
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Notes | Country of origin: Washington, USA. RDAD: In own home, 12 x 1 hour sessions, 2 per week for the first 3 weeks, followed by 1 for the next 4 weeks and biweekly sessions over the following 4 weeks. Followed by 3 sessions over the next 3 months conducted by health professionals experienced in dementia care. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 'Patient caregiver dyads were randomly assigned to exercise plus behavioural management techniques or routine medical care' |
Allocation concealment (selection bias) | Low risk | The random allocation sequence was obtained from a computer program that blocked groups of 8 patients. Dyads were randomised after baseline assessment by research coordinators. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | A manual was used. Treatment adherence maintained and monitored through weekly supervision. Treatment sessions were videotaped and reviewed by independent reviewers. Unsure as to the level of blinding of other personnel and participants other than outcome assessment interviewers. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessments conducted by blind interviewers. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All reported (43 institutionalised, 2 declined to continue, 2 caregivers were ill, 2 moved, 5 caregivers declined to continue, 9 patients died and 1 caregiver died). |
Selective reporting (reporting bias) | Unclear risk | Behavioural data not reported. |
Other bias | Unclear risk | Training by authors |