Table 1 Self-report measures used with people with dementia and response rates (studies arranged by dementia severity)

Studies collecting data from people with mild to moderate dementia only:

 [44] Clare L, Kudlicka A, Oyebode JR, Jones RW, Bayer A, Leroi I, et al. Goal-oriented cognitive rehabilitation for early-stage alzheimer’s and related dementias: The GREAT RCT. Health Technol Assess. 2019 Mar 1;23(10):1–244

Included study: RCT of goal-oriented cognitive rehabilitation

N = 474

Mild to moderate

Mean MMSE 23.82, ranging from 18 to 30

Self-reported measures:

BGSI

DEMQOL

GSES

HADS (depression and anxiety)

RBMT

TEA (with and without distraction)

D-KEFS VF

Primary outcome was self-reported goal attainment at 3 months

Baseline: (N = 474)

BGSI: 474/474 (100%)

DEMQOL: 472/474 (99.6%)

GSES: 469/474 (98.9%)

HADS D: 472/474 (99.6%)

HADS A: 472/474 (99.6%)

RBMT: 473/474 (99.8%)

TEA: 463/474 (97.7%)

TEA WD: 448/474 (94.5%)

D-KEFS VF: 470/474 (99.2%)

T1 (3 months): (N = 445)

BGSI: 445/445 (100%)

DEMQOL: 445/445 (100%)

GSES: 439/445 (98.7%)

HADS D: 444/445 (99.8%)

HADS: A: 442/445 (99.3%)

RBMT I: 444/445 (99.8%)

RBMT D: 442/445 (99.3%)

TEA: 429/445 (96.4%)

TEA WD: 406/445 (91.2%)

D-KEFS VF: 444/445 (99.8%)

T2 (9 months): (N = 426)

BGSI attainment 416 (97.7%)

BGSI satisfaction 412/426 (96.7%)

DEMQOL 417/426 (97.8%)

GSES: 401/426 (94.1%)

HADS D: 404/426 (94.8%)

HADS A: 403/426 (94.6%)

RBMT I: 411/426 (96.5%)

RBMT D: 410/426 (96.2%)

TEA: 397/426 (93.2%)

TEA WD: 370/426 (86.9%)

D-KEFS VF: 409/426 (96.0%)

 [45] Clarkson P, Challis D, Hughes J, Roe B, Davies L, Russell I, et al. Components, impacts and costs of dementia home support: a research programme including the DESCANT RCT. Program Grants Appl Res. 2021;9(6):1–132

Included study: Pragmatic randomised trial of dementia home support

N = 468

Mild to moderate

Participants were within one year of a memory clinic diagnosis with mild to moderate dementia (based on clinical assessment)

Self-reported measures:

CASP-19

DEMQOL

SMMSE

EQ-5D-5L

ICECAP-O

Primary outcome measure was BADLS (not self-reported)

Baseline: (N = 468)

CASP-19: 451/468 (96.4%)

DEMQOL:446/468 (95.3%)

SMMSE: 466/468 (99.6%)

T1 (3 months): (N = 371)

CASP 19: 358/371 (96.5%)

DEMQOL: 350/371 (94.3%)

SMMSE: 367/371 (98.9%)

T2 (6 months): (N = 347)

CASP-19: 322/347 (92.8%)

DEMQOL: 323/347 (93.1%)

SMMSE: 340/347 (98.0%)

EQ-5D-5L and ICECAP-O (used for economic analysis) response rates not clearly reported (imputation used)

 [46] Howard R, Zubko O, Gray R, Bradley R, Harper E, Kelly L, et al. Minocycline 200 mg or 400 mg versus placebo for mild Alzheimer’s disease: the MADE Phase II, three-arm RCT. Effic Mech Eval. 2020 Apr 24;7(2):1–62.

Included study: RCT of Minocycline for mild Alzheimer’s Disease

N = 544

Mild

Inclusion criteria specified SMMSE score of > 23 points.

Mean SMMSE score at baseline was 26.4

Self-reported measures:

SMMSE

Primary outcome measure was BADLS (not self-reported)

Screening: (N = 544)

SMMSE: 542/544 (99.6%)

T1 (6 months): (N = 544)

SMMSE: 498/544 (91.5%)

T2 (12 ms): (N = 537)

SMMSE: 453/537 (84.4%)

T3 (18 ms): (N = 528)

SMMSE: 420/528 (79.5%)

T4 (24 ms): (N = 517)

SMMSE: 403/517 (77.9%)

 [47] Kehoe PG, Turner N, Howden B, Jarutyt L, Clegg SL, Malone IB, et al. Losartan to slow the progression of mild-to-moderate Alzheimer’s disease through angiotensin targeting: the RADAR RCT. Effic Mech Eval. 2021;8(19):1–72.

Included study: RCT to study the effects of the antihypertensive drug losartan, in addition to normal care, compared with a placebo

N = 211

Mild to moderate

Inclusion criteria specified that participants had an MMSE score of 15–28 at the consented eligibility assessment. Mean baseline MMSE score was 22

Self-reported measures:

ADAS-Cog

MMSE

DEMQOL

Primary outcome was difference in brain atrophy, measured using brain scans

Baseline: N = 211

ADAS-Cog: 207/211 (98.1%)

MMSE: 209/211 (99.1%)

DEMQOL: 211/211 (100%)

6 months: N = 204

ADAS-Cog: 194/204 (95.1%)

DEMQOL: 202/204 (99.0%)

12 months: N = 197

ADAS-Cog: 182/197 (92.4%)

MMSE: 192/197 (97.5%)

DEMQOL: 186/197 (94.4%)

 [48] Orgeta V, Leung P, Yates L, Kang S, Hoare Z, Henderson C, et al. Individual cognitive stimulation therapy for dementia: A clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Health Technol Assess (Rockv). 2015;19(64):7–73

Included study: RCT of individual cognitive stimulation therapy for dementia

N = 356

Mild to moderate

Clinical Dementia Rating:

70% CDR1

18% CDR 0.5

12% CDR 2

(One participant received a CDR score of 0)

Mean MMSE 21.23

Self-reported measures:

ADAS-Cog

QOL-AD

DEMQOL

GDS-15

QCPR

MMSE

Primary outcome measures were ADAS-Cog and

QOL-AD

Baseline: (N = 356)

ADAS-Cog: 354/356 (99.4%)

QOL-AD: 356/356 (100%)

DEMQOL: 350/356 (98.3%)

GDS-15: 350/356 (98.3%)

QCPR: 348/356 (97.8%)

MMSE: 356/356 (100%)

Week 13: (N = 288)

ADAS-Cog: 278/288 (96.5%)

QOL-AD: 284/288 (98.6%)

DEMQOL: 277/288 (96.2%)

GDS-15: 276/288 (95.8%)

QCPR: 281/288 (97.6%)

MMSE: 285/288 (98.6%)

Week 26: (N = 273)

ADAS-Cog: 262/273 (96.0%)

QOL-AD: 267/273 (97.8%)

DEMQOL: 264/273 (96.7%)

GDS-15: 262/273 (96.0%)

QCPR: 269/273 (98.5%)

MMSE: 268/273 (98.2%)

 [49] Orrell M, Hoe J, Charlesworth G, Russell I, Challis D, Moniz-Cook E, et al. Support at Home: Interventions to Enhance Life in Dementia (SHIELD) – evidence, development and evaluation of complex interventions. Program Grants Appl Res. 2017;5(5):1–184

Included study: RCT of Maintenance Cognitive Stimulation Therapy (MCST)

N = 236 participants were randomised to the MCST or usual care group (half recruited from care homes and half recruited from community settings)

Mild to moderate

Inclusion criteria specified that participants had a CDR of between 0.5 to 2.

‘Most of the sample had moderate dementia, with a mean MMSE score of 16.8 (SD 5.5) and a mean ADAS-Cog score of 34.3 (SD 12.9)’ (pg30)

Self-reported measures:

ADAS-Cog

QOL-AD

EQ-5D

DEMQOL

MMSE

Primary outcome measures were ADAS-Cog

QOL-AD

Response rate by measure not clearly reported.

At follow-up 1 (3 months after baseline) 218 participants (92%) remained in the study and the reported response rate, excluding deaths, was 96%

At follow-up 2 (6 months after baseline) 199 participants (84%) remained in the study and the reported response rate, excluding deaths, was 89%.

Some details were given on how missing data were managed: ‘Complete-case data analysis was used initially to establish the results, followed by the analysis with imputations.…. No data were imputed for those cases in which all assessments were missing. There were no participants missing for follow-up 1 who returned for follow-up 2. Primary analyses used an intention-to-treat basis, analysing participants according to the group to which they were randomised and using all data’ (pp. 29–30)

 [49] Orrell M, Hoe J, Charlesworth G, Russell I, Challis D, Moniz-Cook E, et al. Support at Home: Interventions to Enhance Life in Dementia (SHIELD) – evidence, development and evaluation of complex interventions. Program Grants Appl Res. 2017;5(5):1–184

Included study: Maintenance Cognitive Stimulation Therapy implementation study (observational)

N = 89

Mild to moderate

Inclusion criteria specified that participants had a CDR of between 0.5 to 2.

Self-reported measures:

QOL-AD

MMSE

Primary outcome measure was MMSE

Baseline: (N = 89)

MMSE and QOL-AD scores for all 89 participants were reported.

Follow-up 1:

MMSE and QOL-AD scores reported for 62 participants (69.7%).

Follow-up 2:

MMSE scores available for 55 participants (61.8%), and QOL-AD scores available for 56 participants (62.9%).

 [50] Woods R, Bruce E, Edwards R, Elvish R, Hoare Z, Hounsome B, et al. REMCARE: Reminiscence groups for people with dementia and their family caregivers - Effectiveness and costeffectiveness pragmatic multicentre randomised trial. Health Technol Assess. 2012;16(48):v–116.

Included study: RCT of group reminiscence for people with dementia and carers

N = 487

Mild to moderate

Inclusion criteria specified that participants were in mild to moderate stage of dementia based on CDR

Self-reported measures:

QOL-AD

EQ-5D

QCPR

One primary outcome measure was self-reported QOL-AD. The other was caregivers’ mental health

350 dyads ‘completed the study’.

Response rates not clearly reported by time point.

Studies collecting data from people with all stages of dementia:

 [51] Allan LM, Wheatley A, Smith A, Flynn E, Homer T, Robalino S, et al. An intervention to improve outcomes of falls in dementia: The DIFRID mixed-methods feasibility study. Health Technol Assess. 2019;23(59):1–20

Included study: Feasibility study of a falls intervention

N = 11

All stages eligible

Mean MoCA was 13.6, indicating moderate dementia (full breakdown of scores not reported)

Self-reported measures:

EQ-5D-5L

QOL-AD

MFES

MoCA

Feasibility study, so no primary outcome

Baseline: (N = 11)

EQ-5D-5L: 11/11 (100%)

QOL-AD: 11/11 (100%)

MFES: 11/11 (100%)

MoCA:11/11 (100%)

T1 (12 weeks) (N = 11)

EQ-5D-5L: 10/11 (90.9%)

QOL-AD: 10/11 (90.9%)

MFES: 11/11 (100%)

‘All self-reported and proxy EQ-5D-5L questionnaires that were completed had no missing data for any of the domains.’ (p89)

 [52] Banerjee S, Hellier J, Romeo R, Dewey M, Knapp M, Ballard C, et al. Study of the use of antidepressants for depression in dementia: The HTA-SADD trial- A multicentre, randomised, double-blind, placebo-controlled trial of the clinical effectiveness and cost-effectiveness of sertraline and mirtazapine. Health Technol Assess. 2013;17(7):1–43.

Included study: Multicentre RCT of two antidepressants for people with dementia

N = 326

All stages eligible (one participant excluded because they had severe dementia SMMSE < 8)

Mean (SD) SMMSE at baseline for the 3 groups:

18.2 (7.4); 18.5 (6.7), and 17.6 (6.0)

Self-reported measures:

SMMSE

EuroQOL VAS

DEMQOL

Primary outcome was depression measured by the CSDD (not self-reported)

Baseline SMMSE

Placebo 82/111 (74%)

Sertraline 79/107 (74%)

Mirtazapine 90/108 (83%)

Baseline EuroQOL VAS:

Placebo 92/111 (83%)

Sertraline 86/107 (80%)

Mirtazapine 91/108 (84%)

Baseline DEMQOL:

Placebo 87/111 (78%)

Sertraline 82/107 (77%)

Mirtazapine 91/108 (84%)

‘Data availability’ reported separately for each group at baseline, but not clearly reported for T1 or T2.

 [53] Bowen M, Edgar DF, Hancock B, Haque S, Shah R, Buchanan S, et al. The Prevalence of Visual Impairment in People with Dementia (the PrOVIDe study): a cross-sectional study of people aged 60–89 years with dementia and qualitative exploration of individual, carer and professional perspectives. Heal Serv Deliv Res. 2016;4(21):1–200.

Included study: A cross sectional study of visual impairment in people with dementia

N = 708

All stages eligible

Of those who were able to complete the SMMSE (n = 654):

21.1% (n = 138) had severe cognitive impairment

39.8% (n = 260) moderate

22.2% (n = 145) mild

12.7% (n = 83) very mild 4.3% (n = 28) no cognitive impairment

Self-reported measures:

SMMSE

Primary outcome was the result of eye examination

SMMSE 654/708 (92.4%)

‘Optometrists were able to perform an eye examination, although not necessarily a full eye examination, on all participants living in their own homes (group 1; n = 389). Optometrists were unable to perform any part of the eye examination on eight participants living in care homes (group 2; n = 319).’ (p40)

 [45] Clarkson P, Challis D, Hughes J, Roe B, Davies L, Russell I, et al. Components, impacts and costs of dementia home support: a research programme including the DESCANT RCT. Program Grants Appl Res. 2021;9(6):1–132.

Included study: Prospective observational study of dementia home support

N = 518

Described as ‘later stage dementia’

Mean baseline SMMSE for each indicated moderate dementia on average:

Basic care: 18.11 (SD 7.19) Int care: 15.74 (SD 6.87) Adv care: 16.20 (SD 6.29)

Self-reported measures:

DEMQOL

EQ-5D-5L

SMMSE

Primary outcome measure was BADLS (not self-reported)

Response rates not clearly reported. 389 people with dementia were interviewed at both baseline and 6 month follow-up, but it is not clear what proportion of each self-reported measure was responded to by these individuals, or how complete the measures were.

 [54] Gathercole R, Bradley R, Harper E, Davies L, Pank L, Lam N, et al. Assistive technology and telecare to maintain independent living at home for people with dementia: The ATTILA RCT. Health Technol Assess. 2021;25(19):1–156

Included study: Pragmatic RCT of assistive technology and telecare

N = 495

All stages eligible

Intervention group SMMSE at baseline (n = 248)

0–9: n = 23 (10%)

10–19: n = 79 (36%)

20–25: n = 87 (39%)

26–30: n = 32 (14%)

Control group SMMSE at baseline (n = 247):

0–9: n = 34 (15%)

10–19: n = 96 (43%)

20–25: n = 74 (33%)

26–30: n = 19 (9%)

Self-reported measures:

SMMSE

EQ-5D-5L

Primary outcomes were time to admission to care home and cost-effectiveness (using self-reported EQ-5D-5L)

Baseline: (N = 495)

SMMSE = 444/495 (89.7%)

T1 to T4: (N = 146)

MMSE not reported

EQ-5D-5L: reported in text as follows: ‘Compared with the expected number of responses (given the number of assessments administered), approximately 10% of EQ-5D participant-reported index scores were missing at baseline. At 12 weeks, 13% of intervention participants’ and 20% of control participants’ responses were missing; at 24 weeks, 15% of intervention and 21% of control group participants’ responses were missing; at 52 weeks, 25% intervention and 31% of control group participants’ responses were missing. At 104 weeks, 22% of intervention and 34% of control group participants’ responses were missing.’ (pg 40)

 [55] Gridley K, Brooks J, Birks Y, Baxter K, Parker G. Improving care for people with dementia: development and initial feasibility study for evaluation of life story work in dementia care. Heal Serv Deliv Res. 2016;4(23):1–298.

Included study: Feasibility study life story work with people with dementia (care homes)

N = 39

All stages eligible

Dementia severity not assessed. Likely to be majority moderate to severe as most participants with dementia did not have capacity to give informed consent (43/59)

Self-reported measures:

QOL-AD

DEMQOL

QCPR

Feasibility study so no primary outcome

Baseline: (N = 39)

QOL-AD: 25/39 (64%)

DEMQOL: 12/39 (31%)

QCPR: 13/39 (33%)

Baseline and 1 months:

QOL-AD: 23/39 (59%)

DEMQOL: 12/39 (31%)

QCPR: 7/39 (18%)

Baseline and 2 months:

QOL-AD: 23/39 (59%)

DEMQOL: 12/39 (31%)

QCPR: 5/39 (13%)

Baseline and 6 months:

QOL-AD: 18/39 (46%)

DEMQOL: 12/39 (31%)

QCPR: 4/39 (10%)

 [55] Gridley K, Brooks J, Birks Y, Baxter K, Parker G. Improving care for people with dementia: development and initial feasibility study for evaluation of life story work in dementia care. Heal Serv Deliv Res. 2016;4(23):1–298.

Included study: Feasibility study of life story work with people with dementia (mental health inpatient assessment units)

N = 12

All stages eligible

Dementia severity not assessed. Likely to be severe as none had capacity to give informed consent

Self-reported measures:

QOL-AD

DEMQOL

QCPR

Feasibility so no primary outcome

Baseline: (N = 12)

QOL-AD: 2/12 (16.7%)

DEMQOL: 1/12 (8.3%)

QCPR: 1/12 (8.3%)

Baseline and 1–2 m:

QOL-AD: 0/12 (0%)

DEMQOL: 0/12 (0%)

QCPR: 1/12 (8.3%)

BASELINE AND 6 M:

QOL-AD: 0/12 (0%)

DEMQOL: 0/12 (0%)

QCPR: 0/12 (0%)

 [56] Iliffe S, Wilcock J, Drennan V, Goodman C, Griffin M, Knapp M, et al. Changing practice in dementia care in the community: developing and testing evidence-based interventions, from timely diagnosis to end of life (EVIDEM). Program Grants Appl Res. 2015 Apr;3(3):1–596.

EVIDEM- C: mixed-method longitudinal study looking at incontinence

N = 34

All stages eligible

Baseline MMSE scores (based on 14 completed measures) ranged from 2–26 (mean score 18)

Self-reported measures:

MMSE

DEMQOL

No primary outcome measure

Baseline: (N = 34)

MMSE: 14/34 (41.2%)

DEMQOL: 7/34 (20.1%)

T1, T2 and T3:

No information.

By the end year 3 only 2 participants with dementia remained: ‘10 people with dementia died, six moved to care homes and one withdrew.’ They were unable to follow-up 15 participants with dementia ‘due to time scale’ (p88)

 [57] Kinderman P, Butchard S, Bruen AJ, Wall A, Goulden N, Hoare Z, et al. A randomised controlled trial to evaluate the impact of a human rights based approach to dementia care in inpatient ward and care home settings. Heal Serv Deliv Res. 2018 Mar;6(13):1–134.

Included study: RCT of a human rights based approach to dementia care in inpatient wards and care homes

N = 439 (in total, but not all took part and not all from the start)

All stages eligible

Dementia severity unknown (only 13/332 completed ADAS-Cog at baseline).

All participants were recruited from hospital wards and care homes

Self-reported measures:

ADAS-Cog

QOL-AD

IDEA questionnaire

Primary outcome measure was QOL-AD (self-report and proxy)

Not possible to calculate response rates from stated N of 439.

Baseline: N for QOL-AD is reported as 265, made up of 102 self-reported scores and 163 proxy scores (these were analysed separately), but it is not clear how this relates to the overall sample of 439 people with dementia recruited to the study.

IDEA questionnaire had 67 self-reported scores at baseline and 3 proxy scores. 260 ‘did not complete’

Between baseline and follow-up 122 new participants were recruited.

T1(4 months): N for QOL-AD is reported as 287, made up of 93 self-reported scores and 194 proxy scores

IDEA questionnaire had 36 self-report and 6 proxy scores. 391 ‘did not complete’

 [58] Moniz-Cook E, Hart C, Woods B, Whitaker C, James I, Russell I, et al. Challenge Demcare: management of challenging behaviour in dementia at home and in care homes – development, evaluation and implementation of an online individualised intervention for care homes; and a cohort study of specialist community mental health car. Program Grants Appl Res. 2017;5(15):1–290

Included study: ResCare: Cluster randomised trial of online training for care home staff to deliver interventions for challenging behaviour in dementia. (Study 2)

N = 832 (555 with challenging behaviour)

All stages eligible

Nearly half had severe dementia at baseline:

Baseline CRD:

0 = 4 (0.7%)

0.5 = 18 (3.2%)

1 = 88 (15.9%)

2 = 169 (30.5%)

3 = 273 (49.2%)

Missing = 3 (0.5%)

Self-reported measures:

EQ-5D

QOL-AD

Primary outcome measure was the NPI (not self-reported)

OUTCOMES STUDY (N = 832 at baseline, reducing to 658 at 4-month follow-up): Response rates were too low to justify imputation: ‘Data for the residents’ responses were not imputed, as there were so many missing data (only 376, 174 and 214 out of the total 832 residents answered the EQ-5D index, VAS and QoL-AD, respectively).’ (p57)

ECONOMIC ANALYSIS (N = 428 at baseline)

Calculations based on 206 self-reported EQ-5D scores (48.1%) and 165 self-reported QOL-AD scores (38.6%)

 [58] Moniz-Cook E, Hart C, Woods B, Whitaker C, James I, Russell I, et al. Challenge Demcare: management of challenging behaviour in dementia at home and in care homes…. Program Grants Appl Res. 2017;5(15):1–290.

Included study: FamCare: Observational cohort study of people with dementia and challenging behaviour living at home and their carers (Study 4)

N = 157

All stages eligible

Over 90% had mild to moderate dementia at baseline:

Baseline CDR:

0 = 5 (3.2%)

0.5 = 35 (22.3%)

1 = 59 (37.6%)

2 = 44 (28.0%)

3 = 14 (8.9%)

T1 CDR:

0: = 3 (2.4%)

0.5 = 29 (23.0%)

1 = 45 (35.7%)

2 = 30 (23.8%)

3 = 19 (15.1%)

T2 CDR:

0 = 6 (5.5%)

0.5 = 18 (16.5%)

1 = 39 (35.8%)

2 = 28 (25.7%)

3 = 18 (16.5%)

Self-reported measures:

EQ-5D

QOL-AD

ICECAP-O

QCPR

Primary outcome was the Revised Memory and Behaviour Problems Checklist (not self-reported)

Baseline: N = 157

EQ-5D: 117/157 (74.5%)

QOL-AD: 116/157 (73.9%)

ICECAP-O: 115/157 (73.2%)

QCPR: 115/157 (73.2%)

T1 (mean 2.4 months from baseline): (N = 126)

EQ-5D index: 87/126 (69%)

EQ-5D VAS: 86/126 (68.3%)

QOL-AD: 85/126 (67.5%)

ICECAP-O: 86/126 (68.3%)

QCPR: 86/126 (68.3%)

T2 (mean 6.6 months from baseline): (N = 117)

EQ-5D index: 74/117 (63.2%)

EQ-5D VAS: 73/117 (62.4%)

QOL-AD: 73/117 (62.4%)

ICECAP-O: 72/117 (61.5%)

QCPR: 72/117 (61.5%)

 [59] O’Brien JT, Taylor J-P, Thomas A, Bamford C, Vale L, Hill S, et al. Improving the diagnosis and management of Lewy body dementia: the DIAMOND-Lewy research programme including pilot cluster RCT. Program Grants Appl Res. 2021;9(7):1–120

Included study: Pilot RCT of a management toolkit for Lewy Body Dementia

N = 131

All stages eligible

The majority of participants had mild to moderate dementia at baseline based on reported MMSE data:

Control group MMSE:

Mean 20.1

Median 22

Interquartile range 17–25

Intervention group MMSE

Mean 21.4

Median 22

Interquartile range 19–26

Self-reported measures:

DEMQOL

GDS

MMSE

MoCA

EQ-5D-5L

HADS

Feasibility study, so no primary outcome

Baseline and 6 months: N = 109

DEMQOL: 86/109 (78.9%)

GDS: 92/109 (84.4%)

MMSE: 98/109 (89.9%)

MoCA: 93/109 (85.3%)

EQ-5D-5L: 89/109 (81.7%)

HADS: 101/109 (92.7%)

 [49] Orrell M, Hoe J, Charlesworth G, Russell I, Challis D, Moniz-Cook E, et al. Support at Home: Interventions to Enhance Life in Dementia (SHIELD) – evidence, development and evaluation of complex interventions. Program Grants Appl Res. 2017;5(5):1–184

Included study: RCT of a Carer Supporter Programme and reminiscence intervention

N = 289 dyads (people with dementia and carers).

All stages eligible

The majority had mild to moderate dementia at baseline (94% had CRD scores between 0.5 and 2, the remaining 6% had a CDR of 3).

Self-reported measures:

MMSE

QOL-AD

EQ-5D

DEMQOL

HADS

QCPR

Primary outcomes measures were QOL-AD (self-reported and proxy) and carers’ health related quality of life

Response rates at follow up not clearly reported. Report sets out how missing data were handled in analysis but does not say how much there was at follow-ups, or from which measures: ‘Multiple imputations at time points were conducted; however, no imputation was completed for a dyad if all measures were missing at a time point.’ (p.82)

 [60] Surr CA, Holloway I, Walwyn REA, Griffiths AW, Meads D, Kelley R, et al. Dementia care mapping™ to reduce agitation in care home residents with dementia: The epic cluster rct. Health Technol Assess. 2020;24(16):1–174

Included study: Cluster RCT of dementia care mapping in residential care settings (with a cross sectional element added at 16 months)

Initial sample N = 726 (all care home residents)

All stages eligible

522/697 of the initial sample had moderately severe or severe assessments on the FAST scale at baseline

N = 675 for the cross-sectional element at 16 months (414 from original cohort, 261 newly recruited). Of these, 570 had moderately severe or severe dementia based on FAST

Self-reported measures:

QOL-AD (adapted for use with care home residents)

EQ-5D-5L

Primary outcome measure was CMAI (staff proxy rated)

Baseline: (N = 726)

QOL-AD: 344/726 (47.4%)

T1 (6 months): (N = 578)

QOL-AD: 229/578 (39.6%)

T2 (16 months): (N = 405)

QOL-AD: 145/405 (35.8%)

Cross section: (N = 666)

QOL-AD: 269/666 (40.4%)

EQ-5D-5L self-reported response rate not reported separately from proxy data.