This chapter reports recruitment and retention of participants, and collection and analysis of study data specifically relating to the delivery and fidelity of the intervention, primary outcome measured at 6 months, and secondary outcomes measured at 6 and 12 months.
Study recruitment and follow-up
The study recruited 568 out of 506 (112.3%) of the required sample size from November 2009 to August 2011. Participants were recruited from 15 sites across England, Scotland and Wales, with an average recruitment of 38 participants (range from 5 to 99) per site, with nine sites recruiting > 30 participants. The participant involvement in the trial ended in August 2012, following completion of recruitment and follow-up.
shows that, after an initial lag phase, steady recruitment was achieved with no noticeable seasonal variation.
provides a breakdown of screening figures collected from all sites, in terms of number of invitations sent, number of ‘yes’ replies, number of home screening visits, number randomised and the proportion of recruits per 100 invites. The different approaches were used to varying extents: GP-based approaches being responsible for recruiting 158 out of 568 (27.8%) of randomised participants at a rate of 2.5 per 100 invites, and stroke register-based approaches recruiting 410 out of 568 (72.2%) of randomised participants at a rate of 8.5 per 100 invites. The stroke register data includes participants recruited at outpatient clinics.
Breakdown of participant identification, screening and recruitment numbers from two alternative contact approaches
Follow-up (CONSORT)
shows the CONSORT diagram for the study. The identification of participants was from 11,126 invites, either by letters of invitations or face-to-face approach. The exact breakdowns were not recorded; however, the majority were by letter of invitation. We had ‘yes’ replies from 1448 out of 11,126 (13.0%) approaches to participate in the study with 9678 out of 11,126 (87%) either not responding or providing negative replies. We did not record the number of ‘no’ replies. After initial pre-consent screening, usually by telephone, a further 596 out of 11,126 (5.4%) were considered ineligible. The main reason for ineligibility was that the potential participants felt they got out of the house as much as they wished already. Therefore, 852 out of 11,126 (7.7%) had a further screening visit in their own home from the RA. Overall, 568 out of 852 (66.7%) were found to be eligible to take part. Of the 11,126 letters sent, 568 people were included (5.1%). Of the 284 out of 11,126 (2.6%) who did not enter the study, only 1 out of 11,126 (0.01%) explicitly refused to participate (owing to their desire to be in the intervention group only).
Final CONSORT diagram. a, Participant remained in the trial but no data were collected at that time point.
The baseline questionnaire was completed by 567 out of 568 (99.8%) participants, with the one outstanding being left with the participant and never being received by the study coordinating centre.
Following randomisation, 287 out of 568 (50.5%) participants were allocated to the intervention group and 281 out of 568 (49.5%) to the control group. In the control group, 1 out of 281 (0.4%) participants received two intervention visits in error. In the intervention group, 281 out of 287 (97.9%) of participants received at least one intervention visit. There was no evidence of crossover between the two groups.
Six-month follow-up was measured by the receipt of the 6-month questionnaire booklet by the research team. For the intervention group, 264 out of 287 (92.0%) reached 6-month follow-up. Of the 23 out of 287 (8.0%) who did not reach 6-month follow-up, 3 out of 287 (1.0%) were lost to follow-up, 14 out of 287 (4.9%) withdrew consent and 4 out of 287 (1.4%) died. A further 2 out of 287 (0.7%) did not complete the follow-up but remained in the study, with 266 participants remaining in the intervention group after 6-month follow-up. For the control group, 239 out of 281 (85.1%) reached 6-month follow-up. Of the 42 out of 281 (14.9%) who did not reach 6-month follow-up, 8 out of 281 (2.8%) were lost to follow-up, 29 out of 281 (10.3%) withdrew consent and 5 out of 281 (1.8%) died. Therefore, there were 239 participants remaining in the control group after 6-month follow-up.
Completion of 6- and 12-month follow-ups was defined as return of the fully/partially completed questionnaire booklet to the NCTU. It does not indicate the level of completeness. Six- and 12-month results for individual measures presented later in the chapter indicate the number of participants from which we have analysable data.
There was a differential follow-up rate between the two groups for the 6-month follow-up, with 92.0% collected for the intervention group and 85.1% collected for the control group. However, these were both less than the predefined 20% attrition rates.
Successful data collection at 12-month follow-up was measured by receipt of the 12-month questionnaire booklet. For the intervention group, 232 out of 287 (80.8%) reached 12-month follow-up. Of the 34 out of 287 (266 – 232 = 34; 11.8%) who did not reach 12-month follow-up, 3 out of 287 (1.0%) were lost to follow-up, 17 out of 287 (5.9%) withdrew consent and 8 out of 287 (2.8%) died. A further 6 out of 287 (2.1%) did not complete the follow-up but remained in the study. For the control group 211 out of 281 (75.1%) reached 12-month follow-up. Of the 28 out of 281 (239 – 211 = 28; 10.0%) who did not reach 12-month follow-up, 4 out of 281 (1.4%) were lost to follow-up, 15 out of 281 (5.3%) withdrew consent and 7 out of 281 (2.5%) died. A further 2 out of 281 (0.7%) did not complete the 12-month follow-up but remained in the study.
As with the 6-month follow-up, there were differential follow-up rates between the two groups for the 12-month follow-up. A total of 232 out of 287 (80.8%) of questionnaires were collected for the intervention group and 211 out of 281 (75.1%) collected for the control group. Although the control group follow-up rate was within the defined 20% attrition rate, the overall number of participants with 12-month follow-up data (n = 443) was within the threshold to ensure that the study had adequate power.
summarises the results of who completed the questionnaire and indicates a consistent proportion of participants completed the questionnaires themselves, whereas at 6 and 12 months there were consistent completion rates for both carer and other (16% and approximately 37%, respectively). The ‘other’ completions at baseline were due to the presence of the RA.
Proportion of who completed baseline and follow-up questionnaires
Carer questionnaire follow-up
We received 192 carer questionnaires at baseline, with 100 out of 192 (52.1%) and 92 out of 192 (47.9%) from carers of participants in the intervention and control groups, respectively. We received 148 carer questionnaires at 6-month follow-up, with 84 out of 100 (84.8%) and 64 out of 92 (69.6%) from carers of participants in the intervention and control groups, respectively. We received 127 carer questionnaires at 12-month follow-up, with 71 out of 100 (71.0%) and 56 out of 92 (60.9%) from carers of participants in the intervention group and control, respectively.
Travel diary follow-up
Owing to the volume of travel diaries and the challenges of tracking their status, a decision was taken not to send reminders if the travel diary was not received. Overall, 70.6% of all expected travel diary months were received and assigned, regardless of whether they contained data, to 508 out of 568 (89.4%) of participants (); 73.6% were received for the intervention group and 67.5% from the control group. Overall, 55.1% of participants returned diaries for the full 12 months.
Travel diary follow-up rates
Baseline characteristics
presents a summary of key baseline characteristics of each group. Baseline characteristics of the sample showed the majority of participants to be women, living with others, with a mean age of 71 years (SD 12.1 years). At baseline there was a slight gender imbalance, with a higher proportion of men in the control group than the intervention group (47% vs. 42.2%). Residential status was well balanced between groups with only a slightly higher proportion living alone in the control group (35.2% vs. 33.4%). The average time since stroke was 37 months (SD 43.8 months) for the control group and 43 months (SD 60.1 months) for the intervention group.
Participant baseline characteristics
Baseline scores for mobility, activity measures, GHQ-12 and SWOM were similar in the two groups. However, for the primary outcome measure of quality of life (social functioning score), the control group had a higher mean (50.1 vs. 45.9) and median (50 vs. 37.5) than the intervention group.
Satisfaction with outdoor mobility scores indicated that overall 93.3% of participants were not currently satisfied with their level of outdoor mobility. The remaining participants who indicated SWOM (n = 38) were spread across both groups, in all sites except one, and had no other unusual characteristics.
It is important to clarify the relationship between the ‘SWOM’ (Do you get out of the house as much as you would like?) question as part of the baseline questionnaire and the eligibility criteria of ‘Wishing to get out of the house more often’. On 38 out of 568 (6.7%) occasions, 20 out of 281 (7.1%) in the control group and 18 out of 287 (6.3%) in the intervention group, the participant indicated that he or she met the eligibility criteria during the consent process but answered ‘Yes’ to the ‘SWOM’ question during completion of the baseline questionnaire. On further investigation it appeared that certain participants were viewing these questions within a different context. The eligibility question was related to aspirational view of getting out of the house (i.e. ‘Wishing to get out of the house more often’), whereas the SWOM question was related to day-by-day coping views of getting out of the house. Hence these participants were not classed as ineligible and were included in the analyses.
Delivery of the intervention
Number of therapists by site
There were 29 therapists taking part in this study, who delivered at least one treatment session. There was no restriction on how many therapists delivered the intervention at each site. This was mainly determined by how the service was structured, availability of staff to perform the research activity, and delivery of research and treatment costs to the relevant department. The therapists ranged from junior to senior (Agenda for Change bands 4–740). Three were physiotherapists, 17 were occupational therapists and nine were assistant practitioners. The number of therapists per site ranged from 1 to 4, with a median of two per site. A small proportion of visits were attended by two therapists (65/1939; 3.4%). These were mainly as a result of training junior staff and training as part of handover to replacement staff. Generally, only one therapist delivered the intervention while the second therapist observed as part of training.
Number and duration of intervention sessions
The intervention group received a median of seven intervention sessions (IQR 3–11 sessions), mean 6.80 sessions (SD 4.01 sessions).
illustrates the distribution of intervention visits received by participants, ranging from zero intervention sessions (6/287, 2.1%) to the maximum 12 (61/287, 21.3%); 138 out of 287 (48.1%) received less than the median of seven visits, with 149 out of 287 (51.9%) receiving ≥ 7 visits. These were calculated from eCRF intervention visit data.
Range of intervention visits.
Of the 287 intervention participants, paper intervention records completed by the therapists were returned for 269 out of 287 (93.7%) participants, 264 out of 287 (92.0%) of whom had received at least one treatment session. The median duration in total, in minutes, of intervention provided for these 264 participants was 369.5 minutes (IQR 170–691.5 minutes), mean 454.6 minutes (SD 352.20 minutes). These were calculated from intervention records data.
Description of set goals
summarises the types of goals set for each participant. Of the 287 participants in the intervention group, information on goals set was recorded for 243. Participants were able to set more than one goal during the process. However, we have no direct measure, relating to individual goals set, to indicate the proportion of goals that were achieved. Instead, we have an overall measure of whether the intervention was delivered to the satisfaction of the therapist, detailed later in
. The most common goal was a long walk of > 100 m, set by 55.1% of participants, whereas increasing confidence was set for 36.2%. There was a wide range of goals set and the vast majority were considered appropriate for an intervention aimed at getting participants out of the house and were also considered attainable.
Summary of type of goals set with participants in the intervention group
Percentage intervention completed to satisfaction by site and average number of session delivered
Description of the key elements of the intervention
The average duration of an intervention visit, including travel to and from the participant’s home, was 96.6 minutes with a range of 10–390 minutes. A total of 1856 out of 1939 (95.7%) intervention visits were completed within the protocol guidelines of 4 months post baseline visit. The other 4.3% were outside the 4-month protocol guidance, although not all were recorded as protocol deviations by the therapists.
summarises the proportion and type of intervention delivered to participants. Goal setting was delivered for 243 (92.1%) participants, with a median of two sessions provided (IQR 1–4 sessions). Mobility training was delivered the most often for a median of 5.5 visits for 222 participants (84.1%), and had the longest duration, with a median of 212.5 minutes (IQR 80–390 minutes) (data not reported in the table). Confidence building was used with 202 (76.5%) participants, with a median of four sessions provided (IQR 2–8 sessions). The least used treatment method was adaptive equipment training, with 63 (23.9%) participants receiving a median of one session (IQR 1–2 sessions). All treatment techniques listed on the record form were used at least once by each site.
Summary of type of intervention and the number of sessions the intervention type was delivered
Treatment fidelity
Of the 15 sites delivering the intervention, 14 were assessed for fidelity of treatment.
Treatment fidelity forms were completed for 59 out of 287 (20.6%) intervention participants. Fidelity of treatment assessments were not performed equally across sites, ranging from the intervention sessions for 10 out of 59 (17.0%) participants assessed at one site to 1 out of 59 (1.7%) participant at each of two sites, and no participants at one site.
Initially, the fidelity of treatment assessment was a combination of checking treatment records against a predefined checklist and also accompanying the treating therapists on visits. However, owing to the possibility that accompanying the therapists on visits might influence how a therapist undertook these sessions, it was decided that only reviewing the participants’ notes would be completed for the remainder. Of the 59 fidelity of treatment assessments, 12 (20.3%) were completed using the visit and the treatment notes and 47 out of 59 (79.7%) were completed by just assessing the treatment notes.
The final question asked the assessor to make a judgement as to whether the intervention had met the standard based on the checklist. They indicated that in 100% of the cases they believed it had.
Completion of intervention
At the end of the participant’s intervention period the therapist indicated in 193 out of 287 (67.3%) of participants that they, the therapists, felt that the participant had completed the intervention to the therapist’s satisfaction (i.e. a surrogate marker for achieving their set goals).
Contamination
There was one participant allocated to the control group who received two intervention visits in error. This was recorded as a protocol deviation and is reported later in the chapter. The nature of the study, with the intervention requiring a visit to the participant’s home, as well as the fact that all participants were not currently within the rehabilitation service, meant that participants in the control group were unlikely to have any contact with local site therapists and hence contamination was unlikely to occur. There is no evidence of any contamination within this study.
Numbers analysed
illustrates the flow of participants and their data; however, it does not provide the details on an outcome-by-outcome basis. A partially completed outcome at the particular follow-up was required for unadjusted measures. In order for any unadjusted outcome measure (apart from travel journeys) to be calculated, the particular measure must be at least partially completed at both baseline and at the particular follow-up. For travel journeys, the participant had to return at least one travel diary to be included in either unadjusted or adjusted analysis.
details the number of participants analysed for both adjusted and unadjusted outcome measure analysis.
Numbers analysed for each outcome measure
Primary outcome
The primary outcome was the Social Function domain within the SF-36v2 relating to an improvement in participant’s quality of life. The predefined MCID was 12.5.32
summarises the primary outcome analysis. The variability of the social function score was similar in the two groups although the mean score was slightly higher in the intervention group (47.0) at 6 months compared with the control group (43.9). The adjusted difference in means between groups was 4.630 with a 95% credible interval of –0.549 to 9.848. This suggests a slightly higher social function score in the intervention group but this was not significant and it is less than the pre-defined MCID. The ICCs for the therapist (ICC = 0.0051) and site effects (ICC = 0.0099) are small, and less than we anticipated in our sample size calculations.
Primary outcome analysis at 6 months
Sensitivity analyses of the primary outcome
Sensitivity analysis was conducted, as per the statistical analysis plan, to assess the effect of outliers and missing data. The results of the sensitivity analyses were consistent with those from the main analysis and did not result in any difference in the conclusions drawn.
Secondary outcomes at 6 months
summarises the secondary outcome analysis at 6 months. The unadjusted mean scores in both groups were similar at 6 months for all secondary outcome measures. In the adjusted analyses there was a statistically significant difference observed between groups for travel journeys, with the intervention group being 42% more likely to make a journey than the control group [rate ratio 1.42, 95% confidence interval (95% CI) 1.14 to 1.67]. There were no other outcome differences between groups.
Secondary outcomes at 6 months split by adjusted measure of outcome
There was evidence of a therapist effect on the travel journeys taken but not for any of the other outcome measures. ICCs for therapist and centre effects were small, with ICCs for therapist effect being no greater than 0.0289 and ICCs for site effect being no greater than 0.0234. Therapy effect and site effect could not be calculated for travel journeys.
The other domains from the SF-36v2 were also analysed at 6 months and showed no significant difference between groups.
Outcome measures at 12 months
summaries the secondary outcomes analysis at 12 months. The variability of the social function score in both groups at 12 months was similar to that observed at 6 months but, unlike the 6-month findings, the unadjusted mean social function score at 12 months was slightly less in the intervention group (45.5) compared with the control group (48.1) (see
). The adjusted difference in means (–1.24) indicated that the intervention group scores were lower than the control, although the difference was not significant and no therapy or site effect was observed for this outcome measure.
Secondary outcomes at 12 months split by adjusted measure of outcome
The unadjusted mean scores in both groups were similar for all outcome measures. In the adjusted analysis there was a significant difference for travel journeys in the intervention group; rate ratio 1.76 journeys (95% CI 1.36 to 1.95 journeys). NEADL, RMI, SWOM and GHQ-12 (participant and carer) did not show any observable differences between groups. The ICCs for therapist effect were larger than those calculated for all secondary outcome measures at 6 months, with the exception of GHQ-12 (carer). The ICCs for site effect, however, were smaller at 12 months than at 6 months, apart from NEADL and participant-reported GHQ-12. There was a significant therapist effect for travel journeys at 12 months; however, we are unable to estimate the size of the effect because this is not calculable for this type of data (see
).
Robustness of results
We assessed the robustness of the findings by repeating all analyses and adjusting for the baseline variables gender and residential status in addition to the other covariates already adjusted for in the models. The results of the analyses were consistent with those obtained from our original analysis. We were unable to conduct this analysis for the GHQ-12 carer outcome because the models would not converge.
Sensitivity analyses
The only potential outliers we found were for the GHQ-12 outcome measures for the participant and carers. After Winsorising these potential outliers we re-analysed the data but the findings were consistent with the original analysis. We also conducted a sensitivity analysis using MI to replace missing data but this did not change the findings of the study.
Exploratory/other analyses
Nottingham Extended Activities of Daily Living by category
No significant differences between groups were found for any of the four categories (mobility, kitchen, domestic and leisure) at 6 or 12 months.
Number of sessions by site
details a site-by-site breakdown of the number of sessions delivered by therapists and the corresponding percentage of participants who completed the intervention to satisfaction. The median number of visits for this study was seven so this is a suitable point of comparison within the context of this study. Of the seven sites with a median of < 7 visits, only 3 out of 7 sessions (42.9%) had > 50% of participants who completed the intervention to satisfaction. Of the eight sites whose median was ≥ 7 visits, 8 out of 8 sessions (100.0%) had > 50% of participants who completed the intervention to satisfaction.
The pilot study, however, showed that the intervention was effective with a median of six visits,24 so this is a suitable predefined point of comparison in terms of potential clinical effect. Of the five sites that had a median of < 6 visits, only 2 out of 5 sessions (40.0%) had > 50% of participants who completed the intervention to satisfaction. Of the 10 sites that had a median of ≥ 6 visits, 9 out of 10 sessions (90.0%) had > 50% of participants who completed the intervention to satisfaction. The results are exploratory but are suggestive that the more intervention visits a participant had the more likely they were to complete the intervention to satisfaction.
Number of travel journeys by intervention session
A further exploratory comparison of travel journeys within the intervention group, based on the number of sessions they received, was carried out (). From the pilot study there was evidence that receiving six intervention visits would increase the number of journeys made, therefore it is considered to be a clinically important pre-existing threshold. The difference between travel journeys made by participants in the intervention group was summarised by < 6 and ≥ 6 or more intervention visits at both 6 and 12 months.
Number of journeys made within the intervention group by number of intervention sessions
These data show that participants who had six or more intervention visits were more likely to have a higher number of journeys at both 6 months (167 vs. 148) and 12 months (316 vs. 291). The results are exploratory but suggest that the more intervention visits a participant has the more likely they are to take more journeys beyond the completion of the intervention.
Falls by age category and allocation
All data described in this section were collected from travel diaries.
presents falls data described by age, either < 60 years of age or ≥ 60 years. At randomisation, 104 participants (18.3%) were < 60 years of age, whereas 464 (81.7%) were ≥ 60 years. A total of 52 out of 104 (50%) of the participants aged < 60 years and 216 out of 464 (46.6%) of the participants aged ≥ 60 years had falls. In total, there were 1950 fall-days: 704 (36.1%) in the < 60 years age group and 1246 (63.9%) in the ≥ 60 years group. The median number of fall-days overall was 3 per year (IQR 1–6.5 fall-days). There appeared to be no difference between the median fall days of the two age groups.
Falls data summary by age
presents falls data described by treatment allocation. The proportion of participants who had a fall was similar in each group: 133 out of 281 (47.4%) in the control group and 135 out of 287 (47%) in the intervention group.
Falls data summary by treatment allocation
Comparing changes in satisfaction with outdoor mobility over time
There was very strong evidence that the control group improved markedly. At baseline, 259 out of 281 (92.2%) participants were dissatisfied with outdoor mobility, but at the 6-month assessment this had reduced to 78% (160/205), a 15% reduction. The corresponding reduction in the intervention group was slightly greater (18%), with 268 out of 287 (93.4%) expressing dissatisfaction with outdoor mobility at baseline and 171 out of 227 (75.5%) expressing this at 6-month assessment. This suggests that the control (consisting of the baseline visits and completion of the travel diary) may have affected a change.
Six-month follow-up by follow-up approach
details the questionnaire data collection from the different methods of approach. For 6-month questionnaires we received the questionnaire booklets for 503 out of 568 (88.6%) participants. The overall average difference in days from actual completion to expected due date was +4.7 days (range –33 to +133 days). Of those received, 280 out of 503 (55.7%) were via postal approach, 185 out of 503 (36.8%) were via the RA approach, with the remaining 38 out of 503 (7.6%) via the RA approach after switching from postal approach. RA assistance did not necessarily mean that the RA completed the questionnaire, just that assistance was provided; however, in the majority of cases the RA would ask the questions and complete on the participant’s behalf.
Proportion of questionnaire received according to approach used, at 6 months
Adverse events
Adverse events records (i.e. a fall that required the assistance of a health-care professional) were collected from only participants in the intervention group over the course of delivering the intervention visits. There were 20 adverse events from 17 participants, with the majority of falls occurring at home. Two were recorded as ongoing, with the average mean duration of event being 5.6 days and median duration of 1 day (range 1–44). Overall, there was no effect on the delivery of the intervention and only one led to permanent discontinuation of the intervention.
Overall, 24 participants died, 12 in each group, indicating that the intervention group did not have an increased risk of death compared with what would be expected for this patient group. As part of the safety analysis there was also no significant difference in GHQ-12 score observed between the groups.
Protocol deviations
There were 68 protocol deviations recorded, with 37 out of 68 (54.4%) for visits not performed within the 4-month window (the majority of these were as a result of adverse weather conditions or temporary participant or therapist unavailability). However, from eCRF intervention data there were a total of 83 visits delivered outside the 4-month window, so there was an issue recording these as protocol deviations.
Twenty-five out of the 68 participants (36.8%) recorded other intervention therapy, which refers the intervention being delivered via non-protocol-defined methods (in all of these cases the intervention was delivered either by telephone or letter).
One out of 68 participants (1.5%) in the control group received the intervention (two visits); 1 out of 68 participants (1.5%) was in active rehabilitation at point of recruitment; and 1 out of 68 participants (1.5%) was an eligibility deviation, as the participant was unwell and not fit to receive treatment, whereas 1 out of 68 participants (1.5%) had a consent issue that was later resolved. Finally, 2 out of 68 participants (2.9%) had an intervention delay owing to unforeseen circumstances.
We considered these all to be minor deviations and that they were unlikely to have any effect on the outcome measure. As a result, no action was taken and all of these participants remained in the study and in the final analysis.
Concealment of allocation
There was a total of 223 RA-assisted participant visits at 6 months (see
), for which the participant-reported primary outcome measure was collected. We received blinding assessments for 171 out of 223 (76.7%) [intervention group 88 out of 171 (51.5%); control group 83 out of 171 (48.5%)] RA-assisted participant visits at 6 months (). The RA was unblinded for 87 out of 171 (50.9%) of those visits, with 13 out of 171 (7.6%) unblinded prior to the visit and 74 out of 171 (43.3%) unblinded during the visit. The RAs were unblinded more frequently for participants in the intervention group (48/87, 55.2%) than for those in the control group (39/87, 44.8%), although this is not indicative of any significant difference in unblinding rates between the two groups.
Awareness of treatment allocation of RAs prior to, or during, RA-assisted participant visits of 6 months primary outcome collection
Summary
The study reached its recruitment targets and achieved strong retention rates at 6 months.
Differential follow-up occurred but not to an extent as to affect the power of the study. The attrition rates were greater within the first 6 months of follow-up.
The quality of life (social function) measure (primary outcome) showed no significant difference between groups at 6 months or at 12 months.
Six- and 12-month measures for functional mobility, SWOM, and participant and carer well-being showed no significant differences between groups.
The 6- and 12-month measure of travel journeys showed a significant difference in favour of the intervention group when the therapist and site effect was taken into consideration.
There was no evidence of a therapy or site effect in any of the outcome measures at either 6 or 12 months, apart from travel journeys at 6 and 12 months.
The intervention was delivered a median of seven times across the study as a whole, with 67.3% completed to the satisfaction of the participant; however, there was considerable variation amongst the sites for both these outcomes.
Exploratory data suggest that the more intervention visits a participant receives, the more likely they are to take more journeys beyond the completion of the intervention.
Exploratory data suggest that the more intervention visits a participant had, the more likely they were to complete the intervention to satisfaction.
The control group appears to have benefitted from inclusion in the study by becoming more satisfied with their outdoor mobility over time.
