A digital health home intervention for people within the Alzheimer’s disease continuum: results from the Ability-TelerehABILITation pilot randomized controlled trial

Figures & data

Figure 1. CONSORT diagram of the study.

Figure 2. The ABILITY telerehabilitation system: architecture and functionality. DHC: Digital Health Contents for rehabilitation.

Table 1. Output and outcome measurements.

Domain	Measure	Scoring	Score range	and cut-off
Global Cognitive Level	MoCA	Total score	0–30	17.363
Language	FAS	Total score	0–∞	17.35
	CAT	Total score	0–∞	24.00
Executive Functions	TMT	PART A time	0–∞	93.00
		PART B time	0–∞	282.00
Memory	FCSRT	IFR	0–36	19.59
		ITR	0–36	34.00
		DFR	0–12	6.31
		DTR	0–12	10.00

MoCA: Montreal Cognitive Assessment [23]; FAS: letter verbal fluencies [24]; CAT: categorical verbal fluencies [25]; TMT: Trail Making Test [26]; FCSRT: Free and Cued Selective Reminding Test [27]; IFR: Immediate Free Recall; ITR: Immediate Total Recall; DFR: Delayed Free Recall; DTR: Delayed Total Recall.

Table 2. Demographic characteristics of groups at baseline and comparison results.

	ABILITY	TAU	test	p Value
Demographics
N	15	15	-	-
Males (%)	6 (40.0%)	8 (53.3%)	0.134°	0.714
Age (M ± SD)	78.2 ± 3.95	77.13 ± 6.38	0.551^^	0.586
Education(M ± SD)	9.33 ± 4.01	7.60 ± 2.67	1.393^^	0.174
Global Cognitive Level
MMSE(M ± SD)	25.24 ± 3.17	24.93 ± 3.86	0.234^^	0.817
MoCA(M ± SD)	18.24 ± 4.40	17.96 ± 5.76	0.151^^	0.881
Language
CAT (M ± SD)	22.78 ± 8.92	24.63 ± 9.65	0.545^^	0.590
FAS (M ± SD)	24.05 ± 6.66	26.79 ± 8.31	0.994^^	0.329
Executive Functions
TMTA (M ± SD)	93.80 ± 135.43	119.27 ± 184.13	118.50^§	0.806
TMTB (M ± SD)	219.40 ± 165.46	270.93 ± 199.69	94.00^§	0.461
Memory
IFR (M ± SD)	15.51 ± 7.61	16.45 ± 9.21	0.305^^	0.763
ITR (M ± SD)	31.00 ± 5.72	31.00 ± 7.06	83.50^§	0.233
DFR (M ± SD)	4.21 ± 3.42	5.18 ± 4.17	0.752^^	0.458
DTR (M ± SD)	10.00 ± 2.65	9.80 ± 3.08	105.00^§	0.775

TAU: treatment as usual; M: mean; N: number; SD: standard deviations; °: χ² chi-squared; ^: t independent t-test; ^§: U Mann-Whitney test. CAT: categorical verbal fluencies; DFR: Delayed Free Recall; DTR: Delayed Total Recall; FAS: letter verbal fluencies; IFR: Immediate Free Recall; ITR: Immediate Total Recall; MoCA: Montreal Cognitive Assessment; PE: Period Effect; TAU: Treatment as usual; TMTA: Trail Making Test – part A; TMTB: Trail Making Test – part B.

Table 3. Adherence and balancing in the two groups per week of treatment.

	Week 1	Week 2	Week 3	Week 4	Week 5	Week 6
Adherence
ABILITY (M ± Sd)	0.91 ± 0.26	0.84 ± 0.34	0.80 ± 0.38	0.76 ± 0.40	0.77 ± 0.40	0.81 ± 0.33
TAU (M ± SD)	0.93 ± 0.12	0.72 ± 0.37	0.72 ± 0.38	0.65 ± 0.41	0.41 ± 0.38	0.29 ± 0.40
Comparison	1.106	1.52	1.029	1.132	3.075	3.824
p	0.632	0.178	0.289	0.237	0.008	<0.001
Perceived balancing
ABILITY (M ± SD)	2.80 ± 0.39	2.87 ± 0.32	2.93 ± 0.45	2.89 ± 0.45	3.05 ± 0.46	3.32 ± 0.67
TAU (M ± SD)	2.92 ± 0.44	3.10 ± 0.42	3.36 ± 0.59	3.36 ± 0.60	3.63 ± 0.73	3.40 ± 0.73
Comparison	0.70	1.63	2.02	2.12	2.198	0.24
p	0.491^^	0.278^§	0.054^^	0.046^^	0.041^^	0.842^§

M: mean; SD: standard deviation; ^: t independent t-test; §: U Mann-Whitney test. p-value < 0.05 are reported in bold.

Table 4. System usability scale results.

		L1	L2	L3	L4	L5	L6	L7
SUS	Patients	0%	0%	0%	33%	47%	20%	0%
	Caregivers	0%	0%	0%	14%	36%	29%	21%

L1: worst imaginable; L2: awful; L3: poor; L4: ok; L5: good; L6: excellent; L7: best imaginable; SUS: System Usability Scale.

Table 5. Period effect results on neuropsychological level.

	PET1-T0  M-change	PET2-T1  M-change	Follow-up > Treatment p-value	Follow-up < Treatment p-value
Global Cognitive Level
MoCA	−0.12	0.15	0.517	0.483
Language
FAS	0.50	−0.31	0.860	0.146
CAT	−0.42	−0.15	0.446	0.554
Executive Functions
TMT-A	4.46	23.73	0.137	0.661
TMT-B	3.77	−2.54	0.595	0.086
Memory
IFR	1.88	−2.42	0.999	<0.001
ITR	0.15	−3.61	0.988	0.020
DFR	0.05	−0.17	0.633	0.367
DTR	0.00	−1.00	0.986	0.014

CAT: categorical verbal fluencies; DFR: Delayed Free Recall; DTR: Delayed Total Recall; FAS: letter verbal fluencies; IFR: Immediate Free Recall; ITR: Immediate Total Recall; MoCA: Montreal Cognitive Assessment; PE = Period Effect; TAU: Treatment as usual; TMT-A: Trail Making Test – part A; TMT-B: Trail Making Test – part B. Significant p values are reported in bold. 

Table 6. TE and COE results.

	TE				COE
	Delta M-change		ABILITY > TAU p-value	TAU > ABILITY p-value	Delta M-change		ABILITY > TAU p-value	TAU > ABILITY p-value
	ABILITY	TAU			ABILITY	TAU
Global Cognitive Level
MoCA	0.53	−1.14	0.022	0.978	1.31	−1.85	0.021	0.979
Language
FAS	0.93	0.43	0.364	0.636	2.00	−1.62	0.093	0.907
CAT	1.33	−2.36	0.044	0.956	1.38	−2.54	0.036	0.964
Executive Functions
TMT-A	−4.60	13.29	0.984	0.016	−4.85	61.23	0.917	0.091
TMT-B	−6.27	10.43	0.901	0.099	−27.46	29.92	0.866	0.145
Memory
IFR	2.40	1.21	0.209	0.791	0.02	−1.10	0.294	0.706
ITR	0.80	−1.93	0.020	0.982	−2.46	−4.46	0.388	0.632
DFR	0.067	−0.23	0.387	0.631	−0.23	−0.01	0.601	0.399
DTR	0.00	−0.50	0.315	0.701	−0.92	−1.08	0.626	0.394

MoCA: Montreal Cognitive Assessment; FAS: letter verbal fluencies; CAT: categorical verbal fluencies; TMT-A: Trail Making Test – part A; TMT-B: Trail Making Test – part B; IFR: Immediate Free Recall; ITR: Immediate Total Recall; DFR: Delayed Free Recall; DTR: Delayed Total Recall; TAU: Treatment as usual; TE: Treatment Effect; COE: Carry-Over Effect. Significant p values are reported in bold.

Table 7. PE results on autonomy in daily living and behavioral symptoms.

	PET1-T0 M-change	PET2-T1 M-change	Follow-up > Treatment p-value	Follow-up < Treatment p-value
Autonomy
ADCS Total	−0.58	−8.23	0.982	0.018
Basic activities	−0.25	−1.18	0.901	0.099
Household activities	−0.42	−3.32	0.950	0.050
Communication	0.63	−1.77	0.966	0.034
Outside activities	−0.54	−1.95	0.978	0.022
Behavioral symptoms
NPI
Symptoms	3.27	−3.46	0.772	0.237
Caregiver distress	0.23	−0.36	0.587	0.413

ADCS: Activities of Daily Living Inventory; NPI: Neuropsychiatric Inventory; PE: Period Effect. Significant p values are reported in bold.

Table 8. TE and COE results on autonomy in daily living and behavioral symptoms.

	TE				COE
	M-change		ABILITY > TAU p-value	TAU > ABILITY p-value	M-change		ABILITY > TAU p-value	TAU > ABILITY p-value
	ABILITY	TAU			ABILITY	TAU
Autonomy
ADCS Total	−1.64	0.90	0.732	0.288	−2.83	−14.00	0.765	0.235
Basic activities	−0.43	0.00	0.863	0.154	−0.83	−2.20	0.863	0.154
Household activities	−1.14	0.60	0.936	0.072	−1.83	−5.10	0.936	0.823
Communication	0.714	0.50	0.428	0.572	0.83	−3.20	0.428	0.921
Outside activities	−0.79	−0.20	0.798	0.221	−1.00	−3.50	0.718	0.961
Behavioral symptoms
NPI
Symptoms	1.07	6.20	0.750	0.269	−4.50	5.00	0.750	0.022
Caregiver distress	0.57	0.50	0.486	0.514	−2.92	3.20	0.486	0.036

ADCS: Activities of Daily Living Inventory; NPI: Neuropsychiatric Inventory; TE: Treatment Effect; COE: Carry-Over Effect. Significant p values are reported in bold.

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Data availability statement

Data can be obtained upon reasonable request to the corresponding author.