Background
Process evaluation
Implementation fidelity
Adherence
Potential moderators
Description of the intervention and its theoretical and empirical underpinnings
Theoretical assumptions of the intervention
Structure and content of intervention
The RCT
Methods
Aim
Study design and data collection
Process evaluation
Participants and data sources
Quantitative phase
Adherence | Potential moderators | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Coverage | Content | Frequency | Duration | Participant Responsiveness | Comprehensive-ness of policy description | Strategies to facilitate implementation | Quality of delivery | Recruitment | Context | |
Quantitative data sources | ||||||||||
Enrolment protocol | X | X | ||||||||
Intervention records | X | X | X | X | ||||||
Attrition records | X | X | X | |||||||
Qualitative data sources | ||||||||||
Individual interviews with participants | X | X | X | X | X | X | X | |||
Focus group interviews with intervention personnel | X | X | X | X | X | X | X | X | ||
Trial coordinators’ records | X | X | X |
Qualitative phase
Mixed methods data analyses
Characteristics of participants
Participants
Total sample from RCT
|
Process evaluation sample
| |
---|---|---|
Demographic characteristics
|
Mean (S.D)
|
Mean (S.D)
|
Age at admission (n = 166;14) | 66.7 (12.02) | 59.6 (11.9) |
N (%)
|
N (%)
| |
Gender (n = 166;14) | ||
Female | 68 (41.0) | 6 (42.9) |
Male | 98 (59.0) | 8 (57.1) |
Living situation (n = 166;14) | ||
Live with someone | 116 (69.9) | 10 (71.4) |
Live alone | 50 (30.1) | 4 (28.6) |
Work status pre-stroke (n = 163;14) | ||
Working | 61 (37.4) | 9 (64.2) |
Retired or on disability leave | 86 (52.8) | 5 (35.7) |
Sick leave or under occupational rehabilitation | 16 (9.8) | 0 |
Rehabilitation services at baseline (T1) (n = 166;14) | ||
Physical therapy | 98 (59.0) | 10 (71.4) |
Occupational therapy | 73 (44.0) | 8 (57.1) |
Speech therapy | 30 (18.1) | 4 (28.6) |
Psychologist/psychiatrist | 14 (8.4) | 3 (21.4) |
Home nursing care | 56 (33.7) | 5 (35.7) |
Other rehabilitation services | 22 (13.3) | 1 (7.1) |
No reported rehabilitation services | 52 (31.3) | 4 (28.6) |
Rehabilitation services at 6 months (T2) (n = 143;14) | ||
Physical therapy | 51 (35.7) | 5 (35.7) |
Occupational therapy | 9 (6.3) | 0 (0.0) |
Speech therapy | 16 (11.2) | 4 (28.6) |
Psychologist/psychiatrist | 3 (2.1) | 1 (7.1) |
Home nursing care | 17 (11.9) | 0 (0.0) |
Other rehabilitation services | 17 (11.9) | 3 (21.4) |
No reported rehabilitation services | 66 (46.2) | 5 (35.7) |
Characteristics of the stroke in acute phase
|
N (%)
|
N (%)
|
Type of stroke (n = 149;14) | ||
Ischemic | 128 (85.9) | 9 (64.3) |
Hemorrhagic | 19 (12.8) | 3 (21.4) |
Not specified | 2 (1.3) | 2 (14.3) |
Stroke symptom localization (n = 144;13) | ||
Right side | 65 (45.1) | 6 (46.2) |
Left side | 70 (48.6) | 6 (46.2) |
Bilateral | 7 (4.9) | 1 (7.7) |
Not relevant | 2 (1.4) | 0 (0.0) |
Language impairment at assessment in hospital (n = 129;13) | ||
Yes | 44 (34.1) | 7 (53.8) |
No | 85 (65.9) | 6 (46.2) |
NIHSS classification (n = 126;14) | ||
0–5 | 85 (67.5) | 9 (69.2) |
6–10 | 28 (22.2) | 3 (23.1) |
11–15 | 13 (10.3) | 1 (7.7) |
16+ | 0 (0.0) | 0 (0.0) |
Intervention personnel
Total sample
|
Process evaluation sample
| |
---|---|---|
Demographic characteristics
|
N (%)
|
N (%)
|
Professional background (n = 27;17) | ||
Nurse | 20 (74.1) | 13 (76.5) |
Occupational therapist | 7 (25.9) | 4 (23.5) |
Highest Educational level (n = 27;17) | ||
Bachelor degree | 4 (14.8) | 3 (17.6) |
Continuing education | 9 (33.3) | 9 (52.9) |
Master’s degree | 8 (29.6) | 5 (29.4) |
PhD | 6 (22.2) | 0 (0.0) |
Primary employment (n = 27;17) | ||
Clinical practice | 14 (51.9) | 13 (76.5) |
Education and research | 13 (48.1) | 4 (23.5) |
Type of employment in clinical practice (n = 14;12) | ||
Stroke unit or specialized rehabilitation unit | 10 (71.4) | 9 (75.0) |
General practice | 4 (28.5) | 3 (25.0) |
Part of the research team (n = 27;17) | ||
Yes | 6 (22.2) | 0 (0.0) |
No | 21 (77.8) | 17 (100.0) |
Clinical experience
| ||
Clinical experience, in years (n = 26;17) | ||
Mean | 17.8 | 18.9 |
S.D | 10.06 | 9.17 |
Min-Max | 2–40 | 7.5–40 |
Clinical experience with stroke survivors, in years (n = 26; 17) | ||
Mean | 9.0 | 9.8 |
S.D | 6.05 | 5.25 |
Min-Max | 1–20 | 2–20 |
Results
Adherence and level of intervention fidelity
Adherence
Number of sessions delivered (n = 154) | N (%*) |
---|---|
8
|
120 (77.9)
|
7
|
15 (87.7)
|
6
|
5 (90.9)
|
5 | 4 (93.5) |
4 | 2 (94.8) |
3 | 3 (96.8) |
2 | 3 (98.7) |
1 | 2 (100) |
Total number | 154 (100/100) |
Frequency and duration | All interventions (1–8 sessions) | Incomplete interventions (< 6 sessions) | Complete interventions (≥6 sessions) |
---|---|---|---|
Timeliness – start (days) (n = 147;11;136)
| |||
Mean (s.e) | 49.1 (1.13) | 50.18 (4.98) | 49.01 (1.16) |
95% CI | 46.87;51.33 | 39.08;61.29 | 46.73;51.30 |
SD | 13.66 | 16.53 | 13.47 |
Timeliness – end (days) (n = 150;10;140)
| |||
Mean (s.e) | −12.57 (2.47) | −87.10 (11.24) | −7.24 (1.83) |
95% CI | −17.44;−7.69 | −112.52;−61.68 | −10.86;−3.62 |
SD | 30.22 | 35.54 | 21.65 |
Duration (weeks) (n = 146;10;136)
| |||
Mean (s.e) | 16.88 (0.35) | 6.3 (1.7) | 17.65 (0.25) |
95% CI | 16.18;17.58 | 2.45;10.15 | 17.15;18.16 |
SD | 4.24 | 5.38 | 2.96 |
Levels of fidelity
Adherence measures | Low fidelity N (%) | Medium fidelity N (%) | High fidelity N (%) |
---|---|---|---|
Content and coverage
| |||
Number of sessions (n = 154) | 8 (5.2) | 6 (3.9) | 140 (90.9) |
Frequency and duration
| |||
Timeliness – start (n = 147) | 5 (3.4) | 23 (15.6) | 119 (81.0) |
Timeliness – end (n = 150) | 28 (18.7) | 45 (30.0) | 77 (51.3) |
Duration (n = 146) | 8 (5.5) | 17 (11.6) | 121 (82.9) |
Composite score | |||
Adherence (n = 146) | 6 (4.1) | 23 (15.8) |
117 (80.1)
|
Content moderated by participant responsiveness, comprehensiveness of policy description, strategies to facilitate implementation, and quality of delivery
Participant responsiveness
Comprehensiveness of policy description
The strategies to facilitate implementation
Quality of delivery
Characteristics of the delivered interventions
| External intervention personnel (n = 21) | Members of research team (n = 6) | Total |
---|---|---|---|
Number of interventions delivered (n = 154) | |||
Total N (%) | 75 (48.7) | 79 (51.3) | 154 (100) |
Mean (S.D) | 3.6 (2.27) | 13.2 (10.94) | 5.7 (6.60) |
Min-Max | 1–9 | 3–33 | 1–33 |