Ridder 2013.
Methods | RCT, cross‐over with 2 periods of 6 weeks for the different conditions Quote: "Data were collected in three 15‐week periods during fall 2010, spring 2011 and fall [autumn] 2011." |
|
Participants | Countries: Denmark and Norway 42 people participated from 14 nursing homes (4 in Denmark and 10 in Norway); most were from Norway (76% of participants) 69% women and mean age was 81 years (range 66–96 years) for the 26% of participants for whom this information was available. The participants had a diagnosis of dementia ("stated in medical journal," no criteria mentioned); 40% had AD; for 38% the type was not specified; 22% had other types of dementia such as vascular, Lewy body, frontotemporal or mixed dementia. Eligible people had moderate‐to‐severe dementia. Mean baseline MMSE score: experimental group: 9.84 (SD 5.97); control group: 5.25 (SD 4.83). Global Deterioration Scale means: experimental group: 5.54 (SD 0.69); control group: 5.80 (SD 0.62). Included participants had symptoms of agitation. |
|
Interventions | Experimental group: individual mixed active‐receptive music therapy, a minimum of 12 sessions were offered, but the participants received a mean of 10 sessions (SD 2.82, range 0 to 13). Frequency: twice a week (over 6 weeks). Mean duration: 33.80 (SD 9.91) minutes Control group: received usual care which for some participants meant participating in group sing‐along sessions |
|
Outcomes | Primary outcome: agitation measured with the CMAI. Timeframe adapted from 2, to 1 week (previous week). In addition to the 7‐point frequency scale, a later version of CMAI was used with a 5‐point disruptiveness scale. The frequency scale, CMAI‐fr, ranged from 1 (never) to 7 (several times per hour), and the disruptiveness scale, CMAI‐di, from 1 (not at all) to 5 (extremely). The CMAI‐fr 1‐ to 7‐point scale was transformed to scores 0 to 6, leading to a maximum total score of 66 and the 1‐ to 5‐point CMAI‐di scale was transformed to scores 0 to 4, leading to a maximum total score of 44. Secondary outcome: quality of life measured with the ADRQL. Timeframe adapted from 2, to 1 week (previous week). |
|
Notes | Psychotropic medication use was measured and considered as an outcome Funding: GC Rieber Foundation in Bergen and Aalborg University |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomly allocated to 1 of 2 groups (experimental or control first) but it was not described how. |
Allocation concealment (selection bias) | Low risk | Quote: "[A] concealed sequence procedure" was used, witnessed and signed by someone who was not involved in the study. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind the convener and participants |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Interviewers and proxy respondents were not blinded to the treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only a few values were missing; and sensitivity analyses were performed with last observation carried forward. |
Selective reporting (reporting bias) | Unclear risk | Quote: "The researchers designed the study protocol in collaboration with a group of clinicians from Denmark and Norway," but there is no reference to compare with. |
Other bias | Unclear risk | Funding source might have an interest in the study outcomes. |