Evaluation of the SPAN intervention for people living with young-onset dementia in the community and their family caregivers: a randomized controlled trial

Figures & data

Table 1. Time line of the SPAN-intervention.

Time	Healthcare professional	Person living with YOD and their family caregiver	Content
Start	Face-to-face consultation		Introduction intervention
		Using SPAN workbook
6-week	Face-to-face consultation		Making week schedule with activities
	Telephonic consultation	Using new week schedule
12-week	Face-to-face consultation		Evaluation week schedule
		Using new (adjusted) week schedule
18-week	Face-to-face consultation		Evaluation of SPAN intervention

Figure 1. Flowchart of all participants.

Table 2. Baseline characteristics of participants in the intervention and control groups.

	Total group (n = 61)	Control (n = 26)	Intervention (n = 35)
	Mean ± SD (range) or n (%)	Mean ± SD (range) or n (%)	Mean ± SD (range) or n (%)	P-value^a
Person living with young-onset dementia
Age in years	64.1 ± 5.5 (44-79)	64.4 ± 6.6 (44-79)	63.8 ± 4.6 (53-71)	p=.455
Sex (% men)	43 (70.5%)	20 (76.9%)	23 (65.7%)	p=.404
Land of birth (% the Netherlands)	58 (95.1%)	24 (92.3%)	34 (97.1%)	p=.570
Marital status				p=.755
Married	57 (93.4%)	24 (92.3%)	33 (94.3%)
Not married	3 (4.9%)	1 (3.8%)	2 (5.7%)
Widower or widow	1 (1.6%)	1 (3.8%)	0 (0%)
Living situation (% living together with family caregiver)	56 (91.8%)	24 (92.3%)	32 (91.4%)	p = 1.000
Type of dementia				p=.580
Alzheimer’s dementia	24 (39.3%)	8 (30.8%)	16 (45.7%)
Frontotemporal dementia	13 (21.3%)	7 (26.9%)	6 (17.1%)
Vascular dementia	11 (18.0%)	5 (19.2%)	6 (17.1%)
Lewy Body dementia	4 (6.6%)	1 (3.8%)	3 (8.6%)
Another form of dementia	9 (14.7%)	5 (19.2%)	4 (11.5%)
Severity of dementia
Very mild (GDS = 2)	19 (31.1%)	9 (34.6%)	10 (28.6%)	p=.980
Mild (GDS = 3)	23 (37.7%)	8 (30.8%)	15 (42.9%)
Moderate (GDS = 4)	7 (11.5%)	4 (15.4%)	3 (8.6%)
Moderately severe (GDS = 5)	5 (8.2%)	2 (7.7%)	3 (8.6%)
Severe (GDS = 6)	4 (6.6%)	2 (7.7%)	2 (5.7%)
Years since diagnosis	2.5 ± 2.7 (0-13)	3.3 ± 2.9 (0-13)	2 ± 2.4 (0-10)	p=.070
Educational level				p=.588
No education	1 (1.6%)	1 (3.8%)	0 (0.0%)
Low	24 (39.3%)	10 (38.5%)	14 (40.0%)
Middle	21 (34.4%)	10 (38.5%)	11 (31.4%)
High	15 (24.6%)	5 (19.2%)	10 (28.6%)
Comorbidity				p=.950
No comorbidity	23 (37.7%)	9 (34.6%)	14 (40.0%)
One or two comorbidities	21 (34.4%)	9 (34.6%)	12 (34.3%)
Three or four comorbidities	12 (19.6%)	4 (15.4%)	8 (22.9%)
Five or six comorbidities	4 (6.6%)	3 (11.5%)	1 (2.9%)
Family caregiver^b
Age in years	61.6 ± 8.2 (30-76)	61.5 ± 9.2 (37-76)	61.6 ± 7.4 (30-76)	p=.982
Sex (% men)	16 (26.7%)	5 (19.2%)	11 (32.4%)	p=.378
Relation to person with dementia				p=.761
Spouse or partner	56 (93.3%)	24 (92.3%)	32 (94.1%)
Son or daughter (in law)	3 (5.0%)	2 (7.7%)	1 (2.9%)
Sister or brother	1 (1.7%)	0 (0%)	1 (2.9%)

^aDifference between groups.

^bFor one person living with YOD, no family caregiver participated (intervention group).

Table 3. Outcomes for control and intervention group participants.

	Control group (n = 26)		Intervention group (n = 35)
	Baseline	Follow-up	Baseline	Follow-up
	mean ± SD (n)	mean ± SD (n)	mean ± SD (n)	mean ± SD (n)
Person living with young-onset dementia
Self-management abilities^a
SMAS-30 total score	59.3 ± 10.7 (23)	58.1 ± 11.5 (20)	60.4 ± 10.6 (29)	60.2 ± 14.3 (19)
Taking initiatives (subscale)	57.5 ± 16.5 (24)	56.5 ± 16.7 (22)	58.3 ± 13.1 (31)	54.5 ± 22.0 (22)
Self-efficacy (subscale)	74.6 ± 13.5 (24)	74.3 ± 11.0 (21)	76.0 ± 17.7 (31)	76.0 ± 20.2 (21)
Investment behavior (subscale)	60.9 ± 17.9 (24)	60.2 ± 15.4 (22)	57.8 ± 19.1 (30)	57.9 ± 17.6 (22)
Positive frame of mind (subscale)	66.4 ± 12.7 (23)	68.3 ± 17.7 (21)	69.8 ± 14.2 (30)	66.8 ± 18.6 (20)
Multifunctionality (subscale)	44.1 ± 17.6 (24)	40.0 ± 16.4 (22)	43.5 ± 16.2 (30)	42.4 ± 17.8 (22)
Variety (subscale)	56.9 ± 17.0 (24)	54.2 ± 14.9 (22)	51.9 ± 12.8 (31)	57.1 ± 16.7 (22)
Quality of life^a
QOL-AD	2.6 ± 0.3 (25)	2.6 ± 0.3 (21)	2.5 ± 0.3 (32)	2.6 ± 0.3 (18)
Health-related quality of life^a
EQ-5D-5L index	0.7 ± 0.2 (25)	0.8 ± 0.2 (22)	0.8 ± 0.2 (34)	0.8 ± 0.1 (24)
EQ-5D-5L visual analogue scale	72.3 ± 13.2 (24)	70.3 ± 21.2 (23)	73.3 ± 12.5 (33)	68.9 ± 14.3 (23)
Behavior
Daily functioning (IDDD)^b	32.5 ± 18.3 (25)	33.5 ± 21.1 (23)	31.2 ± 19.4 (34)	37.4 ± 17.6 (21)
Apathy (AES-10)^c	25.7 ± 7.9 (26)	25.8 ± 7.7 (24)	25.3 ± 6.3 (32)	26.6 ± 7.2 (21)
Neuropsychiatric symptoms (NPI-Q)^c	8.1 ± 6.4 (26)	7.7 ± 4.9 (24)	8.8 ± 5.9 (34)	7.3 ± 6.2 (21)
Family caregiver
Quality of life^a	7.4 ± 1.0 (26)	7.0 ± 1.1 (24)	7.0 ± 1.2 (34)	6.7 ± 1.1 (21)
Health-related quality of life^a	78.9 ± 12.1 (26)	72.8 ± 17.2 (24)	73.8 ± 14.3 (34)	72.8 ± 13.2 (21)
Caregiver burden^d	4.7 ± 2.2 (26)	5.1 ± 2.2 (24)	4.4 ± 2.5 (34)	5.3 ± 2.4 (21)
Sense of competence^a	26.1 ± 4.7 (21)	25.6 ± 5.7 (23)	25.9 ± 4.3 (29)	25.7 ± 5.9 (20)
Emotional distress^d	11.4 ± 9.4 (25)	10.7 ± 7.6 (24)	11.9 ± 10.0 (34)	12.1 ± 9.1 (19)

^aHigher scores indicate a better score on this outcome measure.

^bHigher scores indicate more need for help.

^cHigher scores indicate more neuropsychiatric or behavioral symptoms.

^dHigher scores indicate more emotional distress or caregiver burden.

Table 4. Intervention effects of the SPAN-intervention on outcome measures.

	Estimated effect of the interaction term (group x time)
	Estimate	95% confidence interval	p-value
Person living with young-onset dementia
Self-management abilities^a
SMAS-30 total score	−1.1	−4.3 − 2.1	0.485
Taking initiatives (subscale)	−1.3	−7.0 − 4.4	0.647
Self-efficacy (subscale)	−0.6	−5.8 − 4.5	0.807
Investment behavior (subscale)	−1.1	−6.2 − 4.0	0.660
Positive frame of mind (subscale)	−1.8	−6.8 − 3.2	0.474
Multifunctionality (subscale)	1.2	−3.5 − 5.9	0.617^e
Variety (subscale)	2.8	−1.6 − 7.2	0.208
Quality of life^a
QOL-AD	0.0	−0.1 − 0.1	0.986
Health-related quality of life^a
EQ-5D-5L index	0.0	0.1 − 0.1	0.402^e
EQ-5D-5L visual analogue scale	−0.6	−4.9 − 3.7	0.768
Behavior
Daily functioning (IDDD)^b	3.9	−0.3 − 8.1	0.066
Apathy (AES-10)^c	0.5	−1.3 − 2.4	0.578^e
Neuropsychiatric symptoms (NPI-Q)^c	−0.3	−1.8 − 1.3	0.741
Family caregiver
Quality of life^a	−0.5	−4.5 − 3.4	0.787^e
Health-related quality of life^a	−0.2	−0.6 − 0.1	0.132^e
Caregiver burden^d	0.3	−0.4 − 1.0	0.326
Sense of competence^a	−0.5	−1.9 − 0.9	0.495^e
Emotional distress^d	0.8	−1.8 − 3.5	0.523

^aHigher scores indicate a better score on this outcome measure.

^bHigher scores indicate more need for help.

^cHigher scores indicate more neuropsychiatric or behavioral symptoms.

^dHigher scores indicate more emotional distress or caregiver burden.

^eCluster analysis was not possible due to the small variance in the group.

Table A1. CONSORT 2010 Checklist of information to include when reporting a randomized trial.

Section or topic	Item #	Checklist item	Reported on page #
Title and abstract
	1a	Identification as a randomised trial in the title	1
	1b	Structured summary of trial design, methods, results, and conclusions	2
Introduction
Background and objectives	2a	Scientific background and explanation of rationale	3
	2b	Specific objectives or hypotheses	3
Methods
Trial design	3a	Description of trial design (such as parallel, factorial) including allocation ratio	4
	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons	N/A
Participants	4a	Eligibility criteria for participants	4
	4b	Settings and locations where the data were collected	4
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered	4, 5
Outcomes	6a	Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed	5, 6
	6b	Any changes to trial outcomes after the trial commenced, with reasons	N/A
Sample size	7a	How sample size was determined	6, 7
	7b	When applicable, explanation of any interim analyses and stopping guidelines	N/A
Randomisation:
Sequence generation	8a	Method used to generate the random allocation sequence	5
	8b	Type of randomisation; details of any restriction (such as blocking and block size)	5
Allocation concealment mechanism	9	Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned	5
Implementation	10	Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions	5
Blinding	11a	If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how	N/A
	11b	If relevant, description of the similarity of interventions	N/A
Statistical methods	12a	Statistical methods used to compare groups for primary and secondary outcomes	7
	12b	Methods for additional analyses, such as subgroup analyses and adjusted analyses	7
Results
Participant flow	13a	For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome	8
	13b	For each group, losses and exclusions after randomisation, together with reasons	8, Figure 1
Recruitment	14a	Dates defining the periods of recruitment and follow-up	5
	14b	Why the trial ended or was stopped	N/A
Baseline data	15	A table showing baseline demographic and clinical characteristics for each group	8, Table 1
Numbers analysed	16	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups	8, Table 2
Outcomes and estimation	17	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)	8, Table 3
	17b	For binary outcomes, presentation of both absolute and relative effect sizes is recommended	N/A
Ancillary analyses	18	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory	8
Harms	19	All important harms or unintended effects in each group	N/A
Discussion
Limitations	20	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses	10
Generalisability	21	Generalisability (external validity, applicability) of the trial findings	9, 10
Interpretation	22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence	9,10
Other information
Registration	23	Registration number and name of trial registry	2, 7
Protocol	24	Where the full trial protocol can be accessed, if available	N/A
Funding	25	Sources of funding and other support (such as supply of drugs), role of funders	11

Data availability statement

The datasets generated and analysed during the current study are not publicly available, but are available from the corresponding author upon reasonable request.