An Individual Cognitive Stimulation Therapy App for People with Dementia and Carers: Results from a Feasibility Randomized Controlled Trial (RCT)

Figures & data

Figure 1 CONSORT flow diagram: participant flow through feasibility trial. *One dyad who did not receive the intervention in the experimental group was subsequently withdrawn from the study.

Table 1 Demographics of People with Dementia and Carers.

	Total (n = 61)	iCST App (n = 31)	TAU (n = 30)	Tests for Homogeneity – p value
Characteristic
Person with dementia
Age in years: mean, SD	73, 7.67 (range: 50–89)	74.03, 6.83	71.81, 8.52	0.16
Male (%)	42 (69)	22 (71)	20 (67)	0.72
Ethnicity white (%)	59 (97)	29 (93.5)	30 (100)	0.37
Relationship with carer: married (%)	51 (84)	27 (87)	24 (80)	0.39
Lives with spouse/partner (%)	52 (85)	27 (87)	25 (83)	0.94
Education^a: no qualifications or School Leaver O-Levels/GCE (%)	25 (41)	15 (48)	10 (33)	0.51
Taking AchEI medication (%)	43 (70.5)	22 (71)	21 (70)	0.89
Experience with technology: quite a lot or more	13 (22)	9 (29)	4 (13)	0.08
Carer
Age in years: mean, SD	66.89, 10.72 (range: 27–83)	68.52, 8.96	65.15, 12.28	0.15
Female (%)	47 (77)	26 (84)	21 (70)	0.20
Ethnicity white (%)	60 (98)	31 (100)	29 (97)	n/a^b
Education^a: School Leaver O- Levels/GCE or Higher Education (BSc/BA) (%)	33 (54)	17 (55)	16 (53)	0.63
Experience with technology: quite a lot or more (%)	21 (35)	10 (33)	11 (37)	0.65

Notes: ^aEducation categories included no qualifications, school leaver – O levels/GCE, school lever – A levels, higher education (BSc/BA), postgraduate education (MSc/MA/PhD), and other. ^bAll carers were white British with one missing value in the control group. Hence, no variation detected between the two groups.

Table 2 Adjusted Means for Outcome Measures for People with Dementia and Carers in the iCST App and TAU Control Group at FU1

FU1	iCST App	TAU	MD	Difference CI (95%)	Effect Size (SMD)	p value
Person with dementia
ADAS-Cog	16.58	17.94	−1.36	−3.71 to 1.00	0.15	0.253
QoL-AD	37.92	34.80	3.12	−0.48 to 6.73	0.40	0.088
CSDD	4.95	4.93	0.02	−1.46 to 1.51	0.00	0.972
EQ-5D	80.12	73.12	7.00	−2.07 to 16.06	0.37	0.127
QCPR	58.68	58.77	−0.09	−2.44 to 2.25	0.01	0.938
QoL-AD [P]	34.39	34.77	−0.38	−2.35 to 1.59	0.07	0.703
CSDD [P]	4.91	4.02	0.89	−0.74 to 2.53	0.27	0.278
BADLS [P]	9.55	9.55	0.00	−2.04 to 2.05	0.00	0.996
NPI total [P]	12.76	12.29	0.47	−4.74 to 5.66	0.03	0.859
Carer
EQ-5D	88.71	85.22	3.49	−1.61 to 8.57	0.29	0.176
HADS-Anxiety	5.36	5.03	0.33	−1.05 to 1.71	0.08	0.634
HADS-Depression	2.56	3.18	−0.62	−1.70 to 0.47	0.18	0.257
QCPR	56.05	58.07	−2.02	−5.40 to 1.37	0.25	0.236

Abbreviations: MD, mean difference; CI, confidence interval; SMD, standardised mean difference; [P], proxy rated measure.

Table 3 Adjusted Means for Outcome Measures for People with Dementia and Carers in the iCST App and TAU Control Group at FU2

FU2	iCST App	TAU	MD	Difference CI (95%)	Effect Size (SMD)	p value
Person with dementia
ADAS-Cog	17.00	17.48	−0.48	−3.37 to 2.40	0.05	0.735
QoL-AD	38.20	36.50	1.70	−0.45 to 3.86	0.28	0.119
CSDD	4.94	4.87	0.07	−1.76 to 1.92	0.01	0.933
EQ-5D	77.83	77.97	−0.14	−8.61 to 8.33	0.01	0.974
QCPR	58.05	58.88	−0.83	−3.76 to 2.11	0.11	0.574
QoL-AD [P]	33.25	33.13	0.12	−2.36 to 2.61	0.02	0.921
CSDD [P]	5.86	5.03	0.83	−1.35 to 3.01	0.18	0.446
BADLS [P]	9.57	10.58	−1.01	−3.04 to 1.03	0.13	0.324
NPI total [P]	11.86	10.91	0.95	−4.69 to 6.60	0.07	0.736
Carer
EQ-5D^a	86.58	78.89	7.69	2.32 to 13.06	0.53	0.006
HADS-Anxiety	5.28	5.72	−0.44	−2.04 to 1.15	0.09	0.575
HADS-Depression	3.28	3.14	0.14	−0.95 to 1.23	0.04	0.798
QCPR	57.42	57.40	0.02	−2.93 to 2.97	0.00	0.990

Note: ^aSignificant result at p < 0.05.

Abbreviations: MD, mean difference; CI, confidence interval; SMD, standardised mean difference; [P], proxy rated measure.

Table 4 ACCEPT for a Full-Scale RCT with the iCST App⁴¹

Component of Trial		Monitoring Methods	Amend?	Outcomes
Trial design		Reviewed suitability of and adherence to research protocol.	No	Trial design and related components are appropriate.
Sample size		Tested assumptions within protocol on: number of sites; recruitment rates; retention rates; and SD of primary outcomes.	Yes	Revision necessary in terms of sample size calculation; recruiting capacity; trial period; and funding.
Interventions	Clinical governance	Assessed compliance with formal training in intervention through contact with local PIs.	Yes	Enhance formal training and supervision of local researchers and/or research nurses at each site eg, by additional training visits and/or catch-ups.
	Intervention fidelity	Measured & assessed adherence to intervention through weekly telephone calls and analytics.	Yes	Enhance supervision of intervention using identifiable analytics. Extend the iCST app with more relevant activities and provide more guidance in its use eg, through the involvement of a formal carer.
Participants	Recruitment strategy	Assessed participant flow per recruitment source.	Yes	Refine recruitment strategy eg, by promoting engagement within recruitment sources (eg, memory clinics) and include other sources such as the Alzheimer’s Society.
	Eligibility criteria	Assessed reasons for ineligible participants and any barriers to recruitment.	Yes	Refine eligibility criteria eg, by making the iCST app compatible with a maximum number of devices.
Consent procedures	Participant information sheets (PIS)	Monitored PIS distribution and emergence of questions related to the PIS through contact with PIs at local site.	No	PIS are appropriate.
	Taking informed consent	Monitored consent documentation and appropriateness of forms through contact with PIs at local site.	No	Consent process and accompanying forms are appropriate.
Randomisation process		Checked randomisation procedures including use of Sealed Envelope, randomisation sequences and accessibility by researchers.	No	Randomisation procedure and training of research team are appropriate.
Blinding		Checked occurrences of unblinding by participants and whether unblinded researchers can keep other researchers blind.	Yes	Extend blinding procedures, eg, by checking whether blinded assessors can predict individual allocations.
Data	Data collection	Assessed adherence to assessments and weekly telephone calls/questionnaires.	Yes	Refine schedules to reduce assessment burden and modify outcome measure selection. Enhance training of research team in data collection tools such as outcome measures to minimise errors and missing data.
	Data quality	Tested missing data procedures listed within the analysis plan.	Yes	Refine missing data procedures in case of assessments missing in full eg, through statistical analyses.
	Data management	Tested suitability of trial database, storage of data, related procedures and software.	Yes	Refine trial database and data monitoring procedures considering the amount of data in larger trial.
Research Governance	Research protocol adherence	Tested adherence to research protocol as widely as possible through regular contact with local PIs.	Yes	Enable quality assurance officer (QAO) to test adherence as widely as possible. Refine protocol to enhance quality assurance plan and training of team.
	Adverse events (AE)	Assessed occurrences and severity of AEs, and reporting procedures.	Yes	Refine AE reporting and assessment procedures through the addition of a QAO.
	Health & Safety (H&S)	Monitored H&S procedures, eg, during installation and assessment visits.	No	Refinement to H&S procedures not necessary.
Data analysis		Tested an analysis plan on the obtained data.	Yes	Refine analysis plan to address research aims in full in terms of effectiveness on outcomes.
Trial management		Reviewed role descriptions of research team including at local sites.	Yes	Extension of research team will be necessary through a Trial Steering Committee and a Data Monitoring Committee. Refine roles eg, depending on workloads.

Notes: Adapted from Charlesworth G, Burnell K, Hoe J et al. Acceptance checklist for clinical effectiveness pilot trials: a systematic approach. BMC Med Res Methodol 13, 78 (2013). Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)⁴¹.

Charlesworth G, Burnell K, Hoe J, Orrell M, Russell I. Acceptance checklist for clinical effectiveness pilot trials: a systematic approach. BMC Med Res Methodol. 2013;13(78). doi:10.1186/1471-2288-13-78

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