Process Evaluation of Home-based Bimanual Training in Children with Unilateral Cerebral Palsy (The COAD-study): A Mixed Methods Study

Figures & data

Table 1. Data collection overview

Time period	Data collection	Participants	Methodology	Process evaluation components
				Fidelity	Dose delivered	Dose received (exposure)	Dose received (satisfaction)	Recruitment	Context
Instructional course for therapists and remedial educationalists	Attendance monitoring	n.a.	QUAN			X
	Questionnaire (n = 22)	Instructors (n = 4) of 16 courses*	QUAN + QUAL	X	X				X
Preparation phase	Questionnaire (n = 14)	Therapists (n = 14)	QUAN + QUAL	X
Home-based training phase	Registration form (n = 11)	Parents (n = 11)	QUAN			X
	Video analysis (n = 136)	Parents (n = 12)	QUAN	X					X
	Interviews (n = 22)	Parents (n = 12)	QUAL	X			X		X
	Questionnaire (n = 28)	Therapists (n = 14) and remedial educationalists (n = 14)	quan + QUAL	X			X		X
Follow-up	Interview (n = 11)	Parents (n = 11)	QUAL	X			X		X
Overall home-based training program	Focus group discussion (n = 3)	Therapists (n = 7) and remedial educationalists (n = 3)**	QUAL	X			X		X
	Drop-out monitoring	n.a.	QUAN + qual					X

n.a.: not applicable; quan: quantitative; qual: qualitative; capitalization represents the dominant strand

* 4 initial courses and 1 refresher course for therapists coaching in the implicit protocol, 5 initial courses and 1 refresher course for therapists coaching in the explicit protocol, 5 initial courses for remedial educationalists

** 3 therapists and 1 remedial educationalist who participated in the focus group discussions performed a member check

Table 2. Participant characteristics

Child characteristics (n = 14)		n	%
Protocol	Implicit Explicit	5 9	36 64
Gender	Male Female	11 3	79 21
Age (years)	2 3 4 5 6 7	3 3 5 1 1 1	21 21 36 7 7 7
MACS level	I II III Not applicable*	1 6 1 6	7 43 7 43
GMFCS level	I II	13 1	93 7
Type of education	Mainstream nursery school or day-care Therapeutic toddler group Mainstream primary school School for physically disabled children Not applicable Missing value	4 1 5 2 1 1	29 7 36 14 7 7
Siblings	1 2 None	9 2 3	64 14 21
Caregiver characteristics of the primary trainer (n = 14)		n	%
Gender	Male Female	1 13	7 93
Relationship to the child	Natural (or adoptive) parent Foster parent	12 2	86 14
Family structure	Traditional family Reconstituted family	13 1	93 7
Highest education completed	Secondary vocational education Senior general secondary education/pre-university education Higher professional education University education	4 1 7 2	29 7 50 14
Working hours per week	0 10–20 20–30 30–40	2 2 7 3	14 14 50 21
Another family member requiring special care or attention	Yes No	2 12	14 86
Caregiver characteristics of the secondary trainer (n = 13)		n	%
Gender	Male Female	10 3	77 23
Relationship to the child	Natural (or adoptive) parent Foster parent Grandparent	11 1 1	85 8 8
Family structure	Traditional family Single-parent family	12 1	92 8
Highest education completed	Pre-vocational secondary education Secondary vocational education Higher professional education University education	1 6 5 1	8 46 38 8
Number of working hours per week	10–20 20–30 30–40 >40	1 3 6 3	8 21 46 21

MACS: Manual Ability Classification System; GMFCS: Gross Motor Function Classification System; * MACS is not validated for children < 4 years of age. For younger included children, the rehabilitation team judged that manual ability was comparable to MACS Level I–III.

Table 3. Results registration form (n = 11)

Child (pseudonym)	Protocol	Minimum weekly training duration (minutes)	Maximum weekly training duration (minutes)	Mean weekly training duration (minutes)	Total training duration (hours)
Julia	Explicit	40	165	106	21.2
Thomas	Explicit	80	160	120	24.1
Emma	Explicit	0	172	129	25.8
David	Implicit	0	260	134	26.8
Ryan	Explicit	0	310	160	31.9
Noah	Implicit	0	265	165	33.0
Kevin	Explicit	105	207	178	35.6
Mike	Implicit	2	340	195	39.0
Robert	Implicit	185	216	203	40.5
Oliver	Explicit	178	277	209	41.9
Alexander	Explicit	160	255	211	42.3

Table 4. Results video analysis (n = 12)

Child (pseudonym)	Protocol	Videos	Intervals	Scorable intervals	Intervals that included task-oriented and/or result-oriented instruction or feedback	Intervals that included instruction or feedback with regard to motor performance
Mike	Implicit	7	100	71	87.3%	18.3%
Samantha	Implicit	8	52	21	81.0%	19.0%
Noah	Implicit	3	27	15	86.7%	20.0%
Robert	Implicit	13	75	57	86.0%	26.3%
Julia	Explicit	40	585	556	98.2%	19.6%
Emma	Explicit	9	126	123	91.9%	29.3%
Kevin	Explicit	3	53	40	97.5%	37.5%
Ryan	Explicit	2	34	28	71.4%	39.3%
Oliver	Explicit	21	145	130	81.5%	45.4%
Thomas	Explicit	20	75	57	78.9%	47.4%
Alexander	Explicit	1	9	9	100%	55.6%
Christian	Explicit	9	70	34	79.4%	61.8%

Table 5. Quantitative results questionnaire evaluation individual programs (n = 14)

Topic therapist questionnaire		Result
Home visits
1.	Participants for which all three home visits took place	43% (6/14)
2.	Period between introduction meeting and first home visit (weeks)	Median 2.0 (range 1.0–3.0)
3.	Period between start of the training and second home visit (weeks)	Median 5.0 (range 4.0–8.0)
4.	Period between start of the training and third home visit (weeks)	Median 11.0 (range 10.0–12.0)
5.	Participants for which an extra home visit took place	0% (0/14)

Some participants returned incomplete questionnaires, resulting in missing values.

Table 6. Quantitative results report form first home visit (n = 14)

Topic		Minutes the topic was discussed(median (range))	Number of parents who sufficiently understood the topic discussed
Instructional videos
1.	Questions of parents	3.5 (0–10)	n.a.
2.	Teaching approach	10.0 (0–75)	100% (12/12)
Home-based training program
3.	Overview of entire 12-week program	10.0 (0–45)	100% (11/11)
4.	Coaching approach	7.5 (1–10)	100% (11/11)
5.	Plan and teaching approach for the first training week	15.0 (2–60)	100% (10/10)
6.	Registration	5.0 (1–10)	80% (8/10)
7.	Video recordings	5.0 (0–10)	100% (10/10)
Setting of home-based training
8.	Available training objects	5.0 (3–10)
9.	Training objects brought by the therapist	5.0 (0–15)
10.	Location of training	5.0 (0–10)
Data sharing system
11.	Setting up data sharing system	5.0 (0–10)
Registration form
12.	Providing the digital registration form to parents	1.0 (0–10)

Some participants returned incomplete questionnaires, resulting in missing values.

n.a.: not applicable

Table 7. Quantitative results questionnaire evaluation individual programs (n = 14)

Topic remedial educationalist questionnaire		Result
1.	Participants for which the telephone appointment took place	77% (10/13)
2.	Period between start of the training and telephone appointment (weeks)	Median 2.6 (range 1.3–4.0)
3.	Participants for which additional appointments took place	0% (0/14)
4.	Participants for which the therapist consulted the remedial educationalist	23% (3/13)

Note: Some participants returned incomplete questionnaires, resulting in missing values.

Table 8. Meta-inference side-by-side comparison table

Research question	Quantitative results	Qualitative results
(1) To what extent was the home-based training program implemented as intended?	- Instructional course: 100% attendance. - Drop-out rate: 22%. - Training duration: median 12.6 weeks (range 11.0–14.7). - Training intensity: median 165 minutes per week, IQR 67.5 (79% of the intended intensity.). - Instruction or feedback with regard to motor performance: 20.9% (SD 3.7) and 42.0% (SD 13.7) of the time in the implicit and explicit protocol, respectively. - Telephone appointments with the therapist every week: 57% of the participants. - All three home visits with the therapist: 43% of participants. - Telephone appointment with the remedial educationalist: 77% of participants. - Completion of the intended registration form: 72% of participants. - Use of the provided data sharing system: 29% of participants.	Theme 1.1: some protocol deviations occurred with training intensity, motor learning approach, task-specificity, telephone appointments, and home visits Theme 1.2: the data sharing system could not be used as intended
(2) How did parents experience the home-based training program and how did they integrate the program in the context of family life?	Not applicable	Theme 2.1: the goals need to be suitable Theme 2.2: the training should be appealing to the child Theme 2.3: training of activities of daily living were easily implemented Theme 2.4: parents were well able to provide training to their child Theme 2.5: the involvement of the extended family or social environment was limited Theme 2.6: completing the registration form and using the data sharing system was burdensome Theme 2.7: the coaching by the therapist was reinforcing Theme 2.8: the training was time-consuming Theme 2.9: the program duration was too intensive Theme 2.10: the program was demanding for the child Theme 2.11: bimanual performance improved Theme 2.12: the program both positively and negatively affected parents
(3) Which components of the home-based training program did contribute to the impact of the program?	Not applicable	Theme 3.1: the manual, instructional videos, task-analysis, home-based training, video recordings, and coaching by the therapist, including telephone appointments and home visits, were valuable Theme 3.2: the number of telephone appointments and home visits need to be reduced or customized Theme 3.3: the registration form had limited added value Theme 3.4: the added value of the remedial educationalist, including telephone appointment, varied
(4) What contextual factors with regard to children, parents and health care professionals were associated with possible variation in implementation and outcomes between child-parents-health care professionals triads?	Not applicable	Theme 4.1: child- and parent-related factors can either promote or hinder training Theme 4.2: motor learning strategies should evolve around the child’s and parents’ needs Theme 4.3: therapist coaching approaches varied