Community Participation by People with Chronic Obstructive Pulmonary Disease

Abstract

Little is known regarding community participation in individuals with chronic obstructive pulmonary disease (COPD). The aim of this study was to explore community participation in individuals with COPD and to determine whether there is an association between community participation and activity-related outcome variables commonly collected during pulmonary rehabilitation assessment. We also sought to investigate which of these variables might influence community participation in people with COPD. Ninety-nine individuals with COPD were enrolled (67 ± 9 years, FEV₁: 55 ± 22% predicted). We assessed community participation (Community Participation Indicator (CPI) and European Social Survey (ESS) for formal and informal community participation), daily physical activity levels (activity monitor), exercise capacity (6-minute walk test), breathlessness (Modified Medical Research Council, MMRC scale), self-efficacy (Pulmonary Rehabilitation Adapted Index of Self-Efficacy) and anxiety and depression (Hospital Anxiety and Depression Scale). Higher levels of community participation on the CPI were associated with older age and greater levels of physical activity (total, light and moderate-to-vigorous) (all r_s = 0.30, p < 0.05). Older age and more moderate-to-vigorous physical activity independently predicted greater community participation measured by CPI. Higher levels of depression symptoms were associated with less formal and informal community participation on ESS (r_s = –0.25). More formal community participation on ESS was weakly (r_s = 0.2–0.3) associated with older age, better lung function, exercise capacity and self-efficacy, and less breathlessness. Self-efficacy, exercise capacity, and age independently predicted formal community participation in individuals with COPD. Strategies to optimize self-efficacy and improve exercise capacity may be useful to enhance community participation in people with COPD.

Keywords:

• Chronic obstructive pulmonary disease
• community participation
• exercise
• physical activity
• pulmonary rehabilitation

Introduction

Community participation is defined by the World Health Organization as “involvement in life situations” that provide interaction with friends, relatives, or members of a community and should be a focus of all disability rehabilitation [1]. Restricted community participation occurs as a result of a dynamic interaction between limitations on activity imposed by disease and personal factors, within the context of an individual’s environment [2]. Although the concept of community participation is well accepted, methods for its evaluation are diverse. In people with chronic obstructive pulmonary disease (COPD), research and clinical outcomes have largely focused on the assessment of dysfunction and limitations of activity, with limited attention to community participation.

People with COPD experience substantial health-related limitations on activities, resulting from symptoms due to primary ventilatory limitation [3] and secondary systemic repercussions such as muscle dysfunction [4]. In addition, personal factors such as anxiety or depression [5] and environmental factors [6] can create social and physical barriers that impact community participation. In older community-dwelling adults, greater mobility, physical function and time spent outside the house are all associated with better community participation [7]. In people with COPD, physical activity participation is associated with better quality of life [8], and socio-environmental factors, including family duties and/or leisure time preferences, are associated with moderate intensity of physical activity, independent of airflow limitation [9]. However, whether there is any relationship between physical activity behavior and community participation has not yet been observed.

Valid measures of community participation are crucial to help identify limitations, which may be amenable to interventions such as pulmonary rehabilitation [10]. Many existing community participation instruments quantify the frequency of involvement in social roles, without addressing the quality of the engagement or participant satisfaction [11]. Recently, two studies have investigated community participation in people with COPD. O’Hoski et al. examined the validity of the Late Life Disability Instrument (LLDI) [12]. Better LLDI scores were associated with better physical function and quality of life in people with COPD [12]. However, the LLDI only identifies the frequency and limitation of role performance, not whether an activity is important to the individual [12]. Michalovic et al. joined with individuals living with COPD to co-create the Activities, Healthcare, and Research Priorities Survey [13]. This survey assesses participation across four domains: i) daily and social activities; ii) physical and movement related activities; iii) self-care; and iv) social engagement. The involvement of people with COPD in developing the survey suggests the categories of assessment are of importance to patients. However, the instrument was designed as a descriptive survey rather than as a standardized measurement tool, so it may not be suitable for measuring change over time with interventions such as pulmonary rehabilitation.

There are currently no accepted tools for the routine assessment of community participation in people with COPD. Desirable characteristics of such a tool would include quantification of how often the individual participates in formal and informal activities, the importance of these activities to the individual, and ease of administration in terms of both length and complexity, as well as robust measurement properties. The Community Participation Indicators (CPI) instrument integrates objective and subjective measures of participation with an approach that quantifies the frequency of participation, relative importance and desire for change [14,15]. A separate tool, the European Social Survey assesses formal (e.g. How often meet socially with friends, relatives or work colleagues?) and informal (e.g. Compared to other people of your age, how often would you say you take part in social activities?) participation using only two questions [16]. Using these tools we set out to describe the relationship between self-reported formal and informal community participation with other activity-related outcome variables, commonly collected during pulmonary rehabilitation assessment. Our hypothesis was that in people with COPD, lower levels of physical activity, poorer exercise capacity and self-efficacy, and more symptoms would be associated with less community participation.

Method

Design

This study used baseline data collected prospectively during the REAcH trial, a randomized, controlled, assessor-blinded equivalence trial comparing home-based telerehabilitation to traditional centre-based pulmonary rehabilitation for people with chronic respiratory disease (ACTRN12616000360415) [17]. Participants were recruited from three tertiary hospitals in metropolitan Melbourne (Alfred Health, Austin Health and Western Health), and one rural hospital in Victoria (Wimmera Health Care Group), Australia.

Participants

To be eligible for inclusion in the main trial individuals had to have a primary diagnosis of a chronic respiratory disease, be aged over 40 years and be able to read and speak English [17]. For inclusion in this analysis participants had to have a diagnosis of COPD based on spirometry (FEV₁/FVC ratio < 0.7), with a smoking history of at least 10 years and age 40 years or older, and have completed both assessment of community participation and objective physical activity monitoring at their baseline assessment. The Human Research Ethics Committee at Alfred Health provided ethical approval for the trial protocol across all sites (HREC15/Alfred/101) with local approval obtained at all other sites. All participants provided written informed consent prior to baseline assessment.

Measurements and outcomes

Community participation indicator (CPI)

The CPI [14] is a self-reported measure of participation that includes 20 items related to productive role activities (e.g. cooking, cleaning), social activities and relationships (e.g. attending community clubs, spending time with family), and recreation and leisure activities (e.g. attending sporting or entertainment events). For each item respondents rate i) the frequency of activity participation (days/hours/occasions); ii) the importance of the activity to them (yes/no); and iii) whether they feel they are doing the activity enough, too much, or not enough. A CPI ratio is calculated by the ratio of the number of important activities engaged in often enough or too much (numerator) to the number of important activities (denominator) across participants as well as for each item [18]. The CPI ratio generates scores between 0 and 1, with higher scores indicating greater participation in activities that are meaningful to the individual. The CPI has been validated in a sample of 1,163 individuals with a variety of chronic health conditions[19]. The CPI is able to distinguish participation between elderly and young adults age groups [18], and is correlated with Stroke Impact Scale (SIS) total scores [20,21].

European social survey—formal and informal community participation

The European Social Survey is a transnational survey administered every two years across Europe since its inception in 2001 [16]. This survey measure individuals’ attitudes, values, beliefs and behaviors as well as assesses community participation through two questions targeting formal and informal participation. Informal participation is assessed on a 7-point scale in response to the question “How often do you meet socially with friends, relatives or work colleagues?” (Never to Every day). Formal participation is rated on a 5-point scale in response to the question “Compared to other people of your age, how often would you say you take part in social activities?” (Much less often than most to Much more than most)—supplementary material Table 1. The ESS has demonstrated good test-retest reliability (intraclass correlation coefficient of 0.86) and excellent validity (r = 0.96) [22].

Physical activity participation

Physical activity participation was assessed objectively using the GeneActiv (Activ Insights Ltd, Kimbolton, Cambridgeshire, UK). The GeneActiv is a validated wrist-worn, tri-axial accelerometer [23], demonstrated to achieve >90% accuracy in classifying activity intensities [24]. The GeneActiv has been used to assess free-living activity in people with COPD [25,26]. The accelerometer was configured to collect data at 85.7 Hz. For physical activity data to be included in this analysis participants required at least 4 days of wear encompassing at least one weekend day [27,28]. A day of data was included if there were at least 10 h of wear within a 24-hour period (0:00–23:59hrs) [29]. Only waking periods were retained in the analysis. The standard conversion of 1 MET = 3.5 mL/kg/min was used and then coded into one of four absolute-intensity categories: sedentary (<1.5 METs), light (1.5–2.99 METs), moderate (3.00–5.99 METs), or vigorous (>6 METs) activity. Average daily PA was calculated as the total of physical activity time (from all physical activity intensities) divided by the number of eligible days. Physical activity time was also stratified according to intensity (i.e. light intensity and moderate-vigorous intensity) and sedentary behavior for analysis [30,31].

Exercise capacity

The 6-minute walk test was performed in accordance with international standards, including performance of two tests [32]. The longest 6-minute walk distance (6MWD) was used for analysis. The 6MWD is a validated measure of functional exercise capacity for COPD [33], and is an important clinical outcome in COPD as it predicts both future hospitalization [34,35] and survival [35].

Self-efficacy

The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) [36] comprises 15 items encompassing the original Generalized Self-Efficacy scale [37] and five specific items related to pulmonary rehabilitation. Each item is scored from 1 to 4, with higher score indicating a higher level of self-efficacy. The PRAISE has demonstrated excellent test-retest reliability (intraclass correlation coefficient of 0.99) and internal consistency (Cronbach’s α 0.95), as well as sensitivity to change in people with COPD after pulmonary rehabilitation [36].

Breathlessness

Perception of breathlessness in daily living was evaluated using the Modified Medical Research (MMRC) dyspnea scale [38], which consists of five statements that describe almost the entire range of dyspnea from none (Grade 0) to almost complete incapacity (Grade 4).

Anxiety and depression

Anxiety and depression were evaluated using the Hospital Anxiety and Depression Scale (HADS) across 14 items, with a score of ≥11 indicative of clinically significant anxiety or depression [39]. The HADS is a valid screening tool for people with COPD [40]. Anxiety and depression are common comorbidities in COPD [41] and can be associated with lower community participation [12].

Statistical analysis

Analyses were performed using Statistical Package for the Social Sciences Version 24 (IBM Corp., Armonk, NY). As this was a retrospective study of available data, no power calculation was performed. Pearson or Spearman correlation coefficients were used, as appropriate, to identify relationships between community participation (dependent variable) and physical activity, exercise capacity, self-efficacy, and breathlessness (independent variables). Independent samples t-tests were used to examine relationships between community participation and binary variables (educational level, currently working metropolitan or rural setting). Results of the univariate analysis determined the variables to be included in a stepwise multiple linear regression analysis examining the relative importance of variables in predicting community participation. Potential predictors of community participation were included in the model if p < 0.1 on univariate analysis. Results are presented as the total percentage of variance that could be explained by the regression model (R²), and β with 95% confidence intervals. A p-value <0.05 was considered statistically significant.

Results

Description of the participants

Ninety-nine participants with COPD were included (Table 1). The mean (standard deviation (SD)) age of participants was 67(9) years, 53% (n = 52) were males, and 29% (n = 29) lived in rural areas. Fifty-two percent of participants were classified as GOLD 3 and 4 and 11 participants (11%) required supplemental oxygen.

Table 1. Participant characteristics.

Characteristics	n = 99
Age (years)	67 (9)
Sex, n male (%)	52 (53)
Currently working, n (%)	14 (14)
Level educational completed high school, n (%)	50 (51)
Living in metropolitan area, n (%)	70 (71)
FEV1 (% predicted)	55 (22)
BMI (kg/m^2)	27 (7)
Pack years (n), median (IQR)	45 [31-63]
Smoking status, n (%)
Ex-smoker	81 (82)
Current smoker	18 (18.2)
mMRC dyspnea, n (%)
Grade 0	1 (1)
Grade 1	33 (33)
Grade 2	38 (38)
Grade 3	22 (22)
Grade 4	5 (5)
HADS anxiety score, median (IQR)	6 [3 − 10]
HADS depression score, median (IQR)	5 [3 − 8]
PRAISE score, median (IQR)	49 [43 − 53]
Long-term oxygen therapy, n (%)
Use	11 (11)
Daily physical activity (min),	331 (125)
LIPA (min)	273 (93)
MVPA (min)	68 (48)
Sedentary time (min)	520 (158)
6-minute walk distance (m)	403 (101)

Results are mean (SD).

FEV₁: forced expiratory volume in one second; BMI: body mass index; mMRC: modified medical research council; HADS: Hospital Anxiety and Depression Scale; LIPA: light intensity physical activity; MVPA: moderate-vigorous intensity physical activity; PRAISE: Pulmonary Rehabilitation Adapted Index of Self-Efficacy.

Community participation

Across all items on the CPI the median [IQR] ratio score was 0.66 [IQR 0.46 to 0.86] (Table 2). Higher CPI ratio scores, reflecting participation in activities that are “significant” and “done enough,” were seen for: managing household bills and expenses (ratio 0.94) and spending time with a significant other or intimate partner (0.84). In contrast, activities identified by participants as ‘important but not being done’ enough included a desire to: go to support groups or self-help meetings (0.23) and work for money (0.27). Results for the frequency and percentage of participants who classify the activity as important and whether the involvement is at least enough, as well as the CPI ratio for each activity, are reported in supplementary material Table 2.

Table 2. Distributions and categories of community participation.

Community participation	n (%)	Median (IQR)
CPI ratio		0.66 (0.46–0.86)
ESS
Informal participation		5 (4–6)
Less participation	17 (17)	2 (1–3)
Higher participation	82 (83)	6 (4–7)
Formal participation		2 (1–3)
Less participation	53 (54)	1 (1–2)
Higher participation	46 (46)	3 (3–5)

CPI: community participation; ESS: European Society Survey; IQR: interquartile range.

Informal community participation assessed using the European Social Survey indicated 83% of participants met with family and friends at least once a week (median score 5 [IQR 4–6]). Conversely, 54% of participants felt that they engaged in social activities less often than other people of their age (median score 2 [IQR 1–3]) (Table 2).

The comparison of subgroups stratified according to the dichotomous variables of demographic characteristics for each measure of community participation is presented in Table 3. However, no significant difference was observed between subgroups for educational level, living area, occupational status and oxygen use.

Table 3. Comparison of community participation according to demographic and oxygen use characteristics.

	CPI	Informal CP	Formal CP
Completed secondary schooling
Yes	0.60 ± 0.28	4.96 ± 1.57	2.40 ± 1.13
No	0.66 ± 0.25	4.96 ± 1.56	2.30 ± 1.01
Living metropolitan area
Yes	0.62 ± 0.27	5.13 ± 1.53	2.36 ± 1.06
No	0.65 ± 0.26	4.62 ± 1.59	2.31 ± 1.10
Currently working
Yes	0.51 ± 0.31	5.21 ± 1.25	2.71 ± 1.32
No	0.65 ± 0.26	4.95 ± 1.58	2.30 ± 1.01
LTOT
Yes	0.64 ± 0.19	5.82 ± 0.87	2.36 ± 0.92
No	0.62 ± 0.27	4.88 ± 1.59	2.34 ± 1.09

Values are expressed as mean ± SD.

*p < 0.05, differences between groups (yes and no) were assessed using independent samples t-tests.

LTOT: Long-term oxygen therapy.

Relationships between measures of community participation and physical activity and clinical outcomes are described in Table 4. A higher CPI ratio score was associated with older age and more time spent physically active (total daily physical activity, LIPA and MVPA). Increased frequency of informal participation, specifically meeting with family and friends, was associated with lower scores for HADS Depression (Table 4). More formal community participation (compared to other people of same age) was weakly associated with older age, better exercise capacity, self-efficacy and less severe disease defined by higher FEV₁% predicted (all r_s = 0.2–0.3, p = 0.01). Lower scores for HADS Depression were associated with increased reporting of formal community participation (Table 4).

Table 4. Associations between community participation and participant factors and pulmonary rehabilitation outcome variables.

	CPI	Informal CP	Formal CP
Age	0.30*	0.07	0.28*
FEV1 (%pred)	0.08	–0.06	0.21*
Total Physical activity	0.28*	–0.08	0.07
LIPA	0.26*	–0.32	0.09
MVPA	0.27*	–0.10	0.08
Sedentary	– 0.11	0.10	–0.12
6MWD	0.09	0.02	0.24*
mMRC dyspnea	– 0.12	–0.03	−0.23*
PRAISE self-efficacy	0.14	0.18	0.28*
HADS_anxiety	–0.04	–0.09	–0.09
HADS_depression	–0.16	–0.25*	–0.33*

CPI: community participation indicators; CP: community participation; FEV₁: forced expiratory volume in one second; LIPA: light intensity of physical activity; MVPA: moderate-vigorous intensity physical activity; 6MWD: six-minute walk distance; mMRC: modified medical research council; PRAISE: Pulmonary Rehabilitation Adapted Index of Self-Efficacy scale. HADS: Hospital Anxiety and Depression Scale.

*Significant correlation at ≤0.05 level.

Factors influencing community participation

A stepwise multiple linear regression model showed that older age and increased participation in moderate-to-vigorous physical activity were independent predictors of community participation, explaining 8% of the variance in CPI ratio score [F_(2,85) = 4.51; p = 0.14; R² = 0.075] (Table 5). High self-efficacy, better exercise capacity and older age were independent predictors of formal community participation (Table 6). These independent variables explained 21% of the variance in formal community participation [F_(3.94) = 9.58; p < 0.001; R² = 0.21].

Table 5. Stepwise multiple linear regression model for Community Participation Indicator.

	Unstandardized coefficient (B)	95% CI	p values	Standardized coefficient (β)
Constant	0.063	–0.370 to 0.497	0.773
Age	0.007	0.001 to 0.013	0.024	0.238
MVPA	0.001	0.000 to 0.002	0.044	0.211

MVPA = moderate-vigorous intensity physical activity.

Table 6. Stepwise multiple linear regression model for formal community participation.

	Unstandardized coefficient (β)	95% CI	p values	Standardized coefficient (β)
Constant	–2.515	–4.565 to –0.464	0.017
PRAISE self-efficacy	0.034	0.005 to 0.064	0.022	0.220
6MWD	0.003	0.001 to 0.005	0.001	0.307
Age	0.028	0.005 to 0.051	0.016	0.236

PRAISE = Pulmonary Rehabilitation Adapted Index of Self-Efficacy; 6MWD = 6-minute walk distance.

Discussion

This study described community participation in individuals with COPD and identified associations between community participation and clinical variables. Specifically, greater community participation was associated with older age, higher physical activity levels, better exercise capacity and self-efficacy and fewer symptoms. In people with COPD community participation was characterized by a median CPI of 0.66.

The deleterious consequences of physical inactivity in individuals with COPD have been well documented and include poorer quality of life [8] as well as increased risk of exacerbations [42] and hospitalizations, and higher mortality [43]. The association of community participation with physical activity behavior is perhaps not surprising given the CPI is based on the framework of the International Classification of Functioning, Disability and Health [14], and both constructs are part of the same component (activity and participation), which are potentially influenced by ventilatory and peripheral dysfunction in individuals with COPD [44]. However, the weak magnitude of this association observed in the present study suggests that other factors may influence these behaviors, such as individual, cultural, seasonal, and environmental attitudes[45]. Although participation in moderate-to-vigorous physical activity is a modifiable behavior, the best way to increase physical activity participation in people with COPD is not clear [46]. As well as the requisite physical capability, engagement in moderate-to-vigorous intensity physical activity encompasses elements such as motivation and self-efficacy [45]. Both dog-walking and grandparenting, activities associated with external and intrinsic motivation [47], have been associated with greater moderate-vigorous physical activity participation in people with COPD, independent of age or symptoms and exercise capacity [9]. Whether a multidisciplinary intervention such as pulmonary rehabilitation that can potentially increase knowledge about the importance of physical activity, improve self-efficacy, and elicit behavior change can also have a positive effect on community participation by people with COPD remains to be explored.

Interestingly, both the community participation indicator and formal community participation were positively associated with age, in contrast to our expectations that younger adults could be more community-engaged than older. Social participation may increase with advancing age up to 80 years, after which there is a decline in participation [48]. The participants studied here were relatively young with a mean age of less than 70 years. It is unclear if these relatively younger participants had family and caring commitments that impacted on their capacity for social participation. A study in healthy elderly people demonstrated that community participation is more a function of productive engagement with others, explained by the activity theory of aging, in which community participation tends to be more associated with psychological, sociological, and cultural influences than other factors [49]. Activity theory of aging is one of three theories of Successful Aging, which recognizes that later life can be a time of engagement, contribution, voluntarism, and well-being [50]. Furthermore, engagement with and support of family and friends are positively associated with community participation [51], however, the proportion of participants in the present study who lived with others is not known. In people with COPD reduced engagement in social activities is associated with an increased risk of both hospitalization and mortality [33,34]. Understanding an individual’s level of community participation, and the possible desire to increase social engagement may impact treatment goals and outcomes [32].

The European Social Survey comprising two single questions to assess community participation, presents a good indicator for formal and informal participation in the general population [16]. In our group of participants with COPD, both formal and informal participation were inversely related to symptoms of depression. In a recent study validating the Late Life Disability Instrument for individuals with COPD, community participation also showed an inverse relationship with depression symptoms [12]. The prevalence of depression in COPD is high [41]. The association between depression and social restriction may be attributed to the inability to perform daily activities due to a decline in functional status associated with disease progression [52]. Another study showed findings from the European Social Survey (2014) of cancer survivors in which greater community participation was associated with a reduced risk of depression [53]. Moreover, greater formal community participation is related to better quality of life and fewer symptoms of depression in the elderly, and is protective for the development and progression of chronic disease [54]. These findings emphasize the importance of identifying depression in people with COPD, and highlight that interventions which encourage and support community participation may be particularly pertinent in this subgroup of people with COPD and depression symptoms.

Our findings relating formal community participation to severity of disease, dyspnea and exercise capacity are in keeping with recent studies which indicate a relationship between 6MWD and community participation [12], and the identification of dyspnea as the most common barrier to community participation by individuals with COPD [13]. This suggests that effective approaches to alleviate breathlessness and improve exercise capacity, such as pulmonary rehabilitation, may help people with COPD participate more regularly in community activities. Michalovic et al. [13], also identified that in individuals with COPD the most common facilitator for community participation was whether the activity was part of their daily routine. Even those experiencing dyspnea during activity were more likely to participate in the activity if it was already part of their usual routine [11]. Interventions that optimize self-efficacy may indirectly impact on community participation by facilitating engagement in self-management behaviors including regular physical activity and performance of daily activities [55,56]. In clinical practice, individuals with COPD referred to pulmonary rehabilitation should be assessed for their want and need of community participation, and strategies could be included to increase their self-efficacy and support their goals for community participation. Whether individualized “training” of community participation, akin to exercise training, might be necessary in order to achieve behavior change is unknown.

A strength of this study is that, in the absence of a gold standard for assessing community participation in individuals with COPD, a brief question about formal community participation could help pulmonary rehabilitation clinicians easily identify individuals who might benefit from behavior change interventions to support activity participation. Moreover, the study includes a participant sample size representative of COPD participants eligible for admission in a pulmonary rehabilitation program and accurate tracking of physical activity in daily life measured objectively by accelerometry.

This study had some limitations. First, the study sample was comprised of people with COPD referred to pulmonary rehabilitation and who had agreed to participate in a study. This may have attracted participants more interested in their self-care and maybe represented people more engaged in the community with higher levels of participation than other people with COPD. Second, measures of community participation are self-reported, which comes with an inherent risk of self-report bias. However, use of self-report methods allowed us to evaluate the importance of community activities to individuals, not just their frequency. An additional limitation is that there was no power calculation performed because this was a secondary analysis of data from a study in which the main objective was not the outcome of community participation. However, we demonstrated significant relationships between community participation and self-efficacy, exercise capacity, and age, suggesting the sample size was sufficient to address the research questions. Furthermore, we do not know whether any of these community participation measures can be responsive to detect changes over time in response to an intervention. There is a scarcity of studies of community participation in COPD, possibly due to the lack of validated instruments. Whether activities associated with a generic or disease specific measure of community participation are meaningful to participants with other conditions or in geographically or culturally diverse locations is unknown. Future studies that investigate other instruments of participation and interventions to increase community participation in people with COPD should be considered.

Conclusion

This study has demonstrated modest associations between greater community participation by people with COPD and patient and disease related factors, including older age, higher physical activity levels, greater exercise capacity, better self-efficacy, fewer symptoms. These relationships were weak, so should be interpreted with caution and confirmed in future studies. The European Social Survey measure of community participation could be a simple, quick and useful tool to include in the assessment of people with COPD, to identify those who require additional support to increase their community participation.

Declaration of interest

The authors report no conflicts of interest.

Additional information

Funding

This work was supported by the Conselho Nacional de Desenvolvimento Tecnológico (CNPq) (process number: 200042/2019-0); and Coordenação de Aperfeiçoamento de Pessoal de Nível Superior—Brazil (CAPES), code 001. The REAcH trial was undertaken with funding from a National Health and Medical Research Council (NHMRC) project grant (GNT1101616). NSC was the recipient of an NHMRC Early Career Fellowship (GNT1119970).