| Methods |
Design: three group three period cross‐over trial
Purpose: examine the effect of 'Simulated Presence' (SimPres) on well‐being in nursing home residents with Alzheimer's disease |
| Participants |
Patients: nursing home residents with Alzheimer's disease |
| Interventions |
Placebo: audio tape of a person reading a text that is not personal nor interactive
Untreated: no audio tape
Experimental: personalised interactive audio tape that contains a telephone conversation with a family member or surrogate.
(Co‐intervention: normal nursing home care) |
| Outcomes |
Mood (multidimensional observation scale for elderly)
Interest (multidimensional observation scale for elderly)
Prevalence of agitated behaviour
Prevalence of withdrawn behaviour
Agitation scale (Cohen‐Mansfield)
Scale for observation of agitation in persons with dementia
Positive affect rating scale
Facial diagrams of mood (FACE) |
| Notes |
Outcome not reported so that meta‐analysis is possible. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
'Latin squares' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Low risk |
'Observers were blinded to the study intervention' |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
High risk |
Outcome not reported so that meta‐analysis is possible. |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 36 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
