Blended psychosocial support for partners of patients with ALS and PMA: results of a randomized controlled trial

Figures & data

Figure 1 Flowchart partners in study.

Table 1 Characteristics of the caregivers in the trial and the patients for whom they provide care (n = 148).

	Intervention (n = 74)	Wait-list (n = 74)
Caregiver characteristics
Gender, n (% female)	48 (64.9)	48 (64.9)
Age in years, mean (SD)	61.8 (10.6)	61.3 (9.8)
Education level, n (%)
Low	28 (37.8)	35 (47.3)
Medium	16 (21.6)	19 (25.7)
High	30 (40.5)	20 (27.0)
Occupation, n (%)
Not working	45 (60.8)	45 (60.8)
Paid work/employment	29 (39.2)	29 (39.2)
Country of birth, n (%)
The Netherlands	68 (91.9)	67 (90.5)
Other	3 (4.1)	2 (2.7)
Missing	3 (4.1)	5 (6.8)
Providing care tasks, n (%)
Yes	59 (79.7)	59 (79.7)
Hours providing care per week, median (inter quartile range)	35 (22–60)	38 (21–56)
Receiving support to deal with caregiving situation n (%)
Yes	19 (25.7)	37 (50.0)
Patient characteristics
Gender, n (% female)	26 (35.1)	27 (36.5)
Age in years, mean (SD)	62.3 (11.0)	62.9 (8.9)
Diagnosis, n (%)
ALS	52 (70.3)	54 (73.0)
PMA	22 (29.7)	20 (27.0)
Time since diagnosis in months, median (inter quartile range)	22.5 (8.0–34.3)	16.00(9.8–44.3)
Level of functioning, mean (SD)
ALSFRS-R	31.7 (9.8)	31.0 (9.5)
ALS-FTD-Q	16.3 (11.8)	17.2 (13.9)
Country of birth, n (%)
The Netherlands	72 (97.3)	65 (87.8)
Other	0 (0.0)	2 (2.7)
Missing	2 (2.7)	7 (9.5)

ALS: Amyotrophic Lateral Sclerosis; PMA: Progressive Muscular Atrophy; ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised; ALS-FTD-Q: Amyotrophic Lateral Sclerosis-Frontotemporal Dementia-Questionnaire; Educational level: low: did not complete secondary school-completed low level secondary school; medium: completed medium level secondary school; high: completed upper level secondary school and/or university degree.

Table 2 Linear mixed model treatment outcome Intervention group vs Wait-list control group.

	Wait-list control group			Intervention group
	Mean (SD)			Mean (SD)			Intervention * time interaction
Caregivers^a	Baseline (n = 74)	3 months (n = 60)	6 months (n = 60)	Baseline (n = 74)	3 months (n = 56)	6 months (n = 46)	b (se)	p-value
Primary outcome
HADS	10.84 (7.19)	11.37 (7.70)	11.48 (7.42)	11.38 (7.12)	10.75 (7.62)	11.00 (7.71)	0.09 (0.38)	0.802
Secondary outcomes
ZBI	13.53 (8.04)	13.62 (7.79)	14.20 (7.58)	13.50 (8.08)	13.18 (7.29)	13.89 (7.76)	−0.19 (0.71)	0.711
CarerQoL-7	10.14 (2.30)	10.10 (2.28)	9.97 (2.09)	10.11 (2.22)	10.63 (2.23)	10.09 (2.23)	−0.11 (0.17)	0.534
CarerQoL-VAS	6.41 (1.43)	6.50 (1.66)	6.25 (1.74)	6.43 (1.55)	6.63 (1.45)	6.43 (1.54)	−0.04 (0.13)	0.735
Intervening variables
RSCSE-Resp	73.43 (22.31)	69.10 (20.70)	69.63 (23.57)	67.81 (25.05)	72.07 (23.00)	67.30 (22.34)	−1.41 (1.93)	0.465
RSCSE-Contr	64.54 (25.36)	58.33 (24.32)	59.13 (27.16)	60.78 (25.87)	62.71 (26.01)	68.26 (23.04)	−5.39 (1.99)	0.007
JCQa	6.28 (1.85)	6.63 (2.02)	6.32 (2.06)	6.41 (1.89)	6.96 (1.88)	6.93 (1.97)	−0.21 (0.21)	0.325
Patients^b	Baseline (n = 43)	3 months (n = 33)	6 months (n = 31)	Baseline (n = 45)	3 months (n = 30)	6 months (n = 24)	b (se)	p-value
Secondary outcomes
HADS	10.42 (5.19)	9.82 (5.69)	11.87 (6.98)	9.42 (6.43)	8.00 (6.72)	9.33 (7.75)	0.20 (0.67)	0.767
MQOL	6.79 (1.41)	6.61 (1.85)	6.52 (2.10)	7.07 (1.34)	6.77 (1.94)	6.63 (1.86)	0.22 (0.21)	0.286

^aLinear mixed model including group, time, intervention*time and adjusted for baseline values of MPSS, SQ, ALSFRS-R, ALS-FTD-Q.

^bLinear mixed model including group, time, intervention*time and adjusted for baseline values of ALSFRS-R, SPBS.

ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised; ALS-FTD-Q: Amyotrophic Lateral Sclerosis-Frontotemporal Dementia-Questionnaire; CarerQoL: Care-related Quality of Life; m: mean; HADS: Hospital Anxiety and Depression Scale; JCQa: Job Content Questionnaire 3 adapted items; MQOL: McGill Quality of Life Questionnaire; MPSS: Multidimensional Scale for Received Support; SD: standard deviation; RSCSE-Resp: Revised scale for caregiving self-efficacy subscale respite care; RSCSE-Contr: Revised scale for caregiving self-efficacy subscale controlling thoughts; SE: standard error; SPBS: Self-Perceived Burden Scale; SQ: Satisfaction Questionnaire; ZBI: Zarit Burden Interview.

A significant group-by-time interaction (p < 0.05) means a significant difference between groups in outcome over time.

Table 3 Linear mixed model treatment outcome Intervention completers vs Wait-list control group.

	Wait-list control group			Intervention completers
	Mean (SD)			Mean (SD)			Intervention * time interaction
Caregivers^a	Baseline (n = 74)	3 months (n = 60)	6 months (n = 60)	Baseline (n = 38)	3 months (n = 37)	6 months (n = 33)	b (se)	p-value
Primary outcome
HADS	10.84 (7.19)	11.37 (7.70)	11.48 (7.42)	9.50 (7.35)	8.22 (6.31)	9.30 (7.06)	0.47 (0.41)	0.256
Secondary outcomes
ZBI	13.53 (8.04)	13.62 (7.79)	14.20 (7.58)	13.13 (8.79)	11.92 (7.43)	12.79 (7.37)	0.50 (0.57)	0.376
CarerQoL-7	10.14 (2.30)	10.10 (2.28)	9.97 (2.09)	10.34 (2.41)	11.16 (1.85)	10.55 (2.09)	−0.24 (0.20)	0.235
CarerQoL-VAS	6.41 (1.43)	6.50 (1.66)	6.25 (1.74)	6.61 (1.46)	6.97 (1.21)	6.76 (1.25)	−0.16 (0.14)	0.262
Intervening variables
RSCSE-Resp	73.43 (22.31)	69.10 (20.70)	69.63 (23.57)	71.53 (24.97)	74.00 (19.22)	72.30 (18.32)	−2.65 (2.13)	0.214
RSCSE-Contr	64.54 (25.36)	58.33 (24.32)	59.13 (27.16)	67.53 (23.94)	68.81 (21.02)	71.39 (19.13)	−4.93 (2.23)	0.028
JCQa	6.28 (1.85)	6.63 (2.02)	6.32 (2.06)	7.00 (1.64)	7.19 (1.79)	6.82 (2.14)	0.11 (0.24)	0.661
Patients^b	Baseline (n = 43)	3 months (n = 33)	6 months (n = 31)	Baseline (n = 23)	3 months (n = 19)	6 months (n = 15)	b (se)	p-value
Secondary outcomes
HADS	10.42 (5.19)	9.82 (5.69)	11.87 (6.98)	9.43 (6.71)	8.58 (6.69)	9.73 (7.95)	0.24 (0.75)	0.747
MQOL	6.79 (1.41)	6.61 (1.85)	6.52 (2.10)	7.17 (1.11)	6.68 (2.03)	6.27 (2.02)	0.43 (0.25)	0.089

^aLinear mixed model including intervention, time, intervention*time and adjusted for baseline values of MPSS, SQ, ALSFRS-R, ALS-FTD-Q.

^bLinear mixed model including intervention, time, intervention*time and adjusted for baseline values of the outcome measure, SPBS, ALSFRS-R.

ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised; ALS-FTD-Q: Amyotrophic Lateral Sclerosis-Frontotemporal Dementia-Questionnaire; CarerQoL: Care-related Quality of Life; m: mean; HADS: Hospital Anxiety and Depression Scale; JCQa: Job Content Questionnaire 3 adapted items; MPSS: Multidimensional Scale for Received Support; MQOL: McGill Quality of Life Questionnaire; SD: standard deviation; RSCSE-Resp: Revised scale for caregiving self-efficacy subscale respite care; RSCSE-Contr: Revised scale for caregiving self-efficacy subscale controlling thoughts; SE: standard error; SPBS: Self-Perceived Burden Scale; SQ: Satisfaction Questionnaire; ZBI: Zarit Burden Interview.

A significant group-by-time interaction (p < 0.05) means a significant difference between groups in outcome over time.

Table 4 Evaluation intervention (n = 53).

Question	Completers (n = 37) Grade 0–10, M (SD)	Non Completers (n = 16) Grade 0–10, M (SD)
Does the support program match your situation?	6.4 (2.4)	5.6 (2.2)
How do you rate the support program in general?	7.9 (1.2)	6.9 (1.4)
How do you rate the information in the support program?	8.1 (1.3)	7.2 (1.3)
How do you rate the exercises in the support program?	7.4 (1.8)	6.9 (1.5)
How do you rate the mindfulness exercises?	5.5 (3.1)	6.1 (2.2)
How do you rate the contact with the professional who provided feedback?	8.6 (1.3)	8.0 (1.1)
How do you rate the user-friendliness of the program?	8.0 (1.2)	7.3 (2.2)
How do you rate the peer contact functions?	6.8 (2.3)	6.5 (2.5)

Data availability

The data that support the findings of this study are available from the corresponding author, JMAVM, upon reasonable request.