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Trial registered on ANZCTR


Registration number
ACTRN12618001983291
Ethics application status
Approved
Date submitted
5/12/2018
Date registered
10/12/2018
Date last updated
10/06/2021
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Coaching and Exercise for Better Walking (ComeBACK) trial
Scientific title
Physical activity coaching for adults with mobility limitations:
a pragmatic randomised controlled trial.
Secondary ID [1] 295895 0
None
Universal Trial Number (UTN)
U1111-1219-7614
Trial acronym
ComeBACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limited mobitity 309359 0
osteoarthritis 310715 0
lower limb fractures 310716 0
stroke 310717 0
brain injury 310718 0
cerebral palsy 310719 0
lower limb amputations 310720 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308227 308227 0 0
Physiotherapy
Musculoskeletal 309428 309428 0 0
Osteoarthritis
Stroke 309429 309429 0 0
Haemorrhagic
Injuries and Accidents 309430 309430 0 0
Fractures
Neurological 309431 309431 0 0
Other neurological disorders
Injuries and Accidents 309432 309432 0 0
Other injuries and accidents
Stroke 309433 309433 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ComeBACK is a three arm trial. Intervention group 1: Coaching to ComeBACK; Intervention group 2: Texting to ComeBACK; Intervention group 3: Texting to ComeBACK later (waitlist control).

Intervention description using the TIDieR checklist.
Why:
Over 1 million Australians currently require assistance to, or are unable to, walk about their homes. The impact of mobility limitation is increasing due to population ageing. Physical activity participation has enormous untapped potential as a cost-effective approach to enhancing health in people of most ages, health conditions and physical abilities, however most people with mobility limitations are insufficiently active for health benefits. Remote interventions such as telephone health coaching and text-message support to encourage physical activity are scalable interventions which can be tailored to match the individual’s capacity and preferences. Physical activity prescription for people with mobility limitations is complex as they face additional barriers to physical activity participation, thus interventions delivered by a health professional such as a physiotherapist is needed. A theoretical basis combining Self Determination Theory, Social Cognitive Theory and Self Regulation Theory informs the choice of intervention components and behaviour change techniques and underpins all participant materials.
Tailoring:
Both interventions (Coaching to ComeBACK and Texting to ComeBACK) are tailored for each participant to address their current mobility limitations and physical inactivity, considering participant goals, exercise preferences and contextual factors (e.g. home environment).

Group 1: Coaching to ComeBACK
What procedures:
*Initial physiotherapy assessment to identify mobility status, safety issues, medical, social and environmental influences on mobility. Three-way (participant/health coach/physiotherapist) handover at end of session if possible.
* Patient-centred health coaching incorporating behaviour change strategies including goal-setting, problem-solving, building social support, experiential learning and motivational interviewing.
What materials:
* Study specific evidence-based and theoretically informed education booklet on physical activity, safe mobility and behaviour change.
* Access to closed study website designed specifically for this study with 3 components: 1) why be active? 2) how to be active (links to resources); 3) how others do it (video case studies-modelling elements of Social Cognitive Theory).
* Physical activity plan shared with General Practitioner.
* Option to use activity monitor and/or physical activity apps for self-monitoring.
Who provided:
* Initial physiotherapy assessment conducted by trained local physiotherapist either employed by the study, paid casually or employed in the local health service.
* Health coaching provided by trained physiotherapists employed by the study with clinical experience working with the study population and research experience delivering telephone-based health coaching. Coaches attended courses through Wellness Coaching Australia; HealthChange Australia and Medicoach as well as receiving training by study investigator (CG) in advanced motivational interviewing, a framework for “good (functional) motivation” and intervention techniques.
How:
* The initial physiotherapy assessment will be conducted face-to-face at the participant’s home or by video conference by a physiotherapist. The three-way handover will be via phone or video conference.
* The health coaching will be delivered via telephone.
* Education booklet, physical activity plan, access details to website designed specifically for this study and activity monitor (optional) will be mailed to participants.
Where:
The intervention will be delivered remotely (apart from initial face to face physiotherapy assessment) to community-dwelling people in Australia, initially commencing in the states of New South Wales, South Australia and Victoria.
When and how much:
* The face-to-face / video conference assessment will occur at the beginning of the intervention period and will last for ~ 1 hour.
* The telephone-based health coaching will occur after the face-to-face assessment, at a tailored frequency and duration (approximately every 2 weeks for 20-30 min) for a total duration of 6 months.
* The education booklet and access details for specific study website will be mailed prior to initial health coaching session. The physical activity plan and activity monitor (if requested) will be mailed (or emailed) after the initial health coaching session.
Groups 2: Texting to ComeBACK
What procedures:
* One-off tailored advice to provide expert assessment of capability, identifying appropriate physical activity opportunities and to build motivation.
* 3-4 times per week (tapering down over time) text messages with some personalisation and tailoring to provide motivation support, planning support, problem-solving and maintenance support.
What materials:
* Study specific evidence-based and theoretically informed education booklet on physical activity, safe mobility and behaviour change.
* Access to closed study specific website with 3 components: 1) why be active? 2) how to be active (links to resources); 3) how others do it (video case studies-modelling elements of Social Cognitive Theory).
* Physical activity plan shared with General Practitioner.
Who provided:
* Tailored advice and personalisation and tailoring of text messages provided by trained physiotherapists employed by the study with clinical experience working with the study population and research experience delivering telephone-based health coaching. Coaches attended courses through Wellness Coaching Australia; HealthChange Australia and Medicoach as well as receiving training by study investigator (CG) in advanced motivational interviewing, a framework for “good (functional) motivation” and intervention techniques.
How:
* The tailored advice will be delivered via telephone.
* Text messages will be pre-scheduled using a web-based short message service to be delivered to the participant’s mobile phone.
* Education booklet, physical activity plan and access details to website will be mailed to participants.
Where:
* The intervention will be delivered remotely to community-dwelling people in Australia, initially commencing in the states of New South Wales, South Australia and Victoria.
When and how much:
* The one-off tailored advice session will occur at the beginning of the intervention period and will last for ~ 1 hour (this could be broken into two calls if the participant fatigues or has limited time).
* The text messages will be pre-scheduled after the advice session to enable tailoring to the participants’ needs and preferences. They will be delivered 3-4x per week (tapering down over time) for 6 months with opt out feature and option to increase or decrease frequency after 1 month.
* The education booklet and access details for study specific website will be mailed prior to health coaching session. The physical activity plan will be mailed (or emailed) after the advice session.

and
Group 3 Texting to ComeBACK later (delayed start)
0-26 weeks post randomisation no study intervention or resources available
from 26 weeks onwards (6 months post randomisation start)
What procedures:
* One-off tailored advice to provide expert assessment of capability, identifying appropriate physical activity opportunities and to build motivation.
* 3-4 times per week (tapering down over time) text messages with some personalisation and tailoring to provide motivation support, planning support, problem-solving and maintenance support.
What materials:
* Study specific evidence-based and theoretically informed education booklet on physical activity, safe mobility and behaviour change.
* Access to closed study designed website with 3 components: 1) why be active? 2) how to be active (links to resources); 3) how others do it (video case studies-modelling elements of Social Cognitive Theory).
* Physical activity plan shared with General Practitioner.
Who provided:
* Tailored advice and personalisation and tailoring of text messages provided by trained physiotherapists employed by the study with clinical experience working with the study population and research experience delivering telephone-based health coaching. Coaches attended courses through Wellness Coaching Australia; HealthChange Australia and Medicoach as well as receiving training by study investigator (CG) in advanced motivational interviewing, a framework for “good (functional) motivation” and intervention techniques.
How:
* The tailored advice will be delivered via telephone.
* Text messages will be pre-scheduled using a web-based short message service to be delivered to the participant’s mobile phone.
* Education booklet, physical activity plan and access details to closed study designed website will be mailed to participants.
Where:
* The intervention will be delivered remotely to community-dwelling people in Australia, initially commencing in the states of New South Wales, South Australia and Victoria.
When and how much:
* The one-off tailored advice session will occur at the beginning of the intervention period (6 months after randomisation (delayed start) and will last for ~ 1 hour (this could be broken into two calls if the participant fatigues or has limited time).
* The text messages will be pre-scheduled after the advice session to enable tailoring to the participants’ needs and preferences. They will be delivered 3-4 times per week (tapering down over time) for 6 months with opt out feature and option to increase or decrease frequency after 1 month.
* The education booklet and access details for study specific designed website will be mailed prior to health coaching session. The physical activity plan will be mailed after the advice session
Intervention code [1] 312222 0
Treatment: Other
Comparator / control treatment
Group 3 Texting to ComeBACK later group (Control for 6 months)
Participants allocated to the Texting to ComeBACK later group will receive the usual care provided by their health service providers for the first 6 months of the study. They will have no contact with the study staff apart from the baseline, 3 and 6-month questionnaires or have no access to any resources. Following the 6-month reassessment they will receive the same intervention as Group 2 (Texting to ComeBACK) as described above. This includes the single phone session of tailored advice from a physiotherapist to improve physical activity (generally 30-45 minutes) as well as text message for 6 months and access to specific study designed online website resources to support being more physically active.
Control group
Active

Outcomes
Primary outcome [1] 307195 0
Physical activity (average number of steps per day) measured over a one-week period with the StepWatch Activity Monitor.
Timepoint [1] 307195 0
At baseline and at 6 months post randomisation.
Secondary outcome [1] 351079 0
Self-reported physical activity will be ascertained using the Incidental and Planned Exercise Questionnaire (IPEQ)
Timepoint [1] 351079 0
Measured at baseline, 3, 6 and 12 months post randomisation
Secondary outcome [2] 351080 0
Pain (specific study developed questions)
Timepoint [2] 351080 0
At Baseline, 3, 6 and 12 months post randomisation
Secondary outcome [3] 351081 0
Quality of life will be assessed using the EuroQol 5D-5L.
Timepoint [3] 351081 0
Measured at baseline, 3 , 6 and 12 months post randomisation
Secondary outcome [4] 351082 0
Lower Limb Extremity function and disability will be measured with the Late Life Function and Disability Instrument.
Timepoint [4] 351082 0
At Baseline, 3, 6 and 12 months post randomisation
Secondary outcome [5] 351083 0
Fear of falling will be measured on a 5 point scale
Timepoint [5] 351083 0
At baseline, 3, 6 and at the 12 month post randomisation
Secondary outcome [6] 351084 0
Achievement of mobilty goals set at baseline will be measured using the Goal Attainment Scale (GAS).
Timepoint [6] 351084 0
Set at baseline and measured at 6 months post randomisation. Reset at 6 months and remeasured at 12 months post randomisation.
Secondary outcome [7] 351085 0
Mental Wellbeing will be measured using the (Warwick-Edinburgh Mental Well-being Scale.
Timepoint [7] 351085 0
At baseline, 3, 6 and 12 months post randomisation
Secondary outcome [8] 351087 0
Rate of Falls will be monitored using the monthly falls calendars for all participants
Timepoint [8] 351087 0
over 12 month time period post randomisation
Secondary outcome [9] 351091 0
Health Utilisation will be collected from same monthly calendars as for falls data
Timepoint [9] 351091 0
over 12 months time period post randomisation
Secondary outcome [10] 351611 0
Impressions of the program will be gathered through questionnaires designed specially for the study intervention programs
Timepoint [10] 351611 0
6 months post randomisation for (Group 1 Coaching to ComeBACK and Group 2 Texting to ComeBACK ) and at 12 months for Group 3 (Texting to ComeBACK later).
Secondary outcome [11] 351612 0
Enjoyment of physical activity in the intervention program will be measured using the Physical Activity Enjoyment Scale (PACES)
Timepoint [11] 351612 0
At 6 months post randomisation for (Group 1 Coaching to ComeBACK and Group 2 Texting to ComeBACK ) and at 12 months for Group 3 (Texting to ComeBACK later).
Secondary outcome [12] 354561 0
Global Perceived Change Scales for physical activity (specific study developed questions)
Timepoint [12] 354561 0
At 3, 6 and 12 months post randomisation
Secondary outcome [13] 354573 0
Cadence (rate a person walks expressed in steps/min) measured over a one-week period with the StepWatch Activity Monitor.
Timepoint [13] 354573 0
At baseline, 6 and 12 months
Secondary outcome [14] 354578 0
BMI (calculated by self reported height in m and weight in kg)
Timepoint [14] 354578 0
at Baseline, 3, 6 and 12months
Secondary outcome [15] 354581 0
Mobility aids (self reported use of mobility aid used by participants)
Timepoint [15] 354581 0
Baseline, 3, 6 and 12 months
Secondary outcome [16] 354742 0
Self reported balance level will be measured on a 5 point scale
Timepoint [16] 354742 0
At baseline, 3, 6 and at the 12 month post randomisation
Secondary outcome [17] 354743 0
Activity intensity levels measured over a one-week period with the StepWatch Activity Monitor.
Timepoint [17] 354743 0
At baseline, 6 and 12 months
Secondary outcome [18] 354744 0
Global Perceived Change Scales for walking (specific study developed question)
Timepoint [18] 354744 0
At 3, 6 and 12 months post randomisation
Secondary outcome [19] 388756 0
Physical activity (average number of steps per day) measured over a one-week period with the Stepwatch Activity Monitor.
Timepoint [19] 388756 0
At 12 months post randomisation
Secondary outcome [20] 388757 0
Work Alliance inventory (WAI) -Short Revised Participant
Timepoint [20] 388757 0
End of intervention period (6 months post randomisation for Group 1 and 2 and 12 months for Group 3)
Secondary outcome [21] 388758 0
Working Alliance Inventory (WAI)- Short revised Therapist
Timepoint [21] 388758 0
End of intervention period (6 months post randomisation for Group 1 and 2 and 12 months for Group 3)
Secondary outcome [22] 388759 0
Attitudes to physical activity is part of the baseline, 3, 6 and 12 month questionnaires. It is a 10 item study specific questionnaire where participants score this attitudes to physical activity on a 5 point scale (strongly agree – strongly disagree)
Timepoint [22] 388759 0
Baseline 3, 6 and 12 months post randoimsation
Secondary outcome [23] 388760 0
Experiences of physical activity is part of the 3, 6 and 12 month questionnaires. It is a 4 item study specific questionnaire where participants score their experience of physical activity on a 5 point scale (strongly agree – strongly disagree)
Timepoint [23] 388760 0
3, 6 and 12 months post randoimsation

Eligibility
Key inclusion criteria
The trial will involve consenting adults who are:
• male or female;
• 18 + years;
• living in the community;
• are able to leave their home without physical assistance from another person (but may use a walking aid);
• have a mobility limitation (self-reported difficulty or inability to walk 800m);
• without major cognitive impairment (diagnosis of dementia or a Memory Impairment Screen score < 5);
• have sufficient hearing and english language skills for a phone-based intervention;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Update
The trial will exclude adults who are:
• residents of residential aged care facilities;
• have the following medical conditions: delirium, acute medical illnesses, severe psychiatric disorders, rapidly progressive neurological diseases;
• have a major cognitive impairment (a diagnosis of dementia or a Memory Impairment Screen score of less than 5);
• currently undertaking 150 minutes of moderate to vigorous physical activity per week (based on self report).
• Full time wheelchair dependent
• Unable to wear a Stepwatch
• Not a regular user of a mobile phone (look at phone < 1/week) or have no internet access

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be determined using REDCap (Research Electronic Data Capture), a centralised web-based randomisation system within The University of Sydney. This will ensure concealment of allocation to groups and an auditable process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will use stratification to ensure balance by recruitment source (health service or community). The randomisation schedule will be created by a researcher not involved in recruitment/eligibility assessment using Stata software (StataCorp) and embedded in the study REDCap database.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Three-arm study. Group 1: Coaching to ComeBACK receives the intervention between 0 to 6 months. Group 2: Texting to ComeBACK received the intervention between 0 to 6 months. Group 3 is a waitlist control and will receive the Texting the ComeBACK intervention from 6 to 12 months.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The trial’s sample size (n=600) will provide 90% power to detect between-group differences of 1000 steps per day assuming a standard deviation of 3000 steps (estimated from our pilot data), a dropout rate of 20%, alpha of 0.0167 (to adjust for multiplicity due to 3 trial arms), and correlation between initial and final measures of 0.6 (from our pilot data). This calculation was undertaken in Stata 13 using the sampsi command. On the basis of previous work by the investigators and others, we consider between-group differences of this magnitude to be achievable and likely to result in significant health benefits because 1000 steps/day, assuming a cadence of 80 steps/min, would equate to an additional 15 minutes of walking/day, a dose associated with health benefits and reduced mortality even in those with cardiovascular disease.

Analysis of covariance, conducted using a linear regression approach, will be used to assess the effect of group allocation on the continuously-scored primary and secondary outcomes after adjusting for baseline scores. Given our interest in comparing the two interventions with each other and with the control condition, between-group differences with p-values < 0.05 will considered significant. Planned sub-group analyses will assess differential effects of the intervention based on the stratification variable of recruitment source, as well as for severity of mobility limitation and age. Secondary analyses using causal modelling will be conducted to establish intervention effects in people with greater adherence. Analyses will be overseen by AI Herbert (clinical epidemiologist), pre-planned, by intention-to-treat, conducted while masked to group allocation, adjusted for the stratification variable and will explore use of multiple imputation for missing primary outcome data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/12/2018
Actual
13/02/2019
Date of last participant enrolment
Anticipated
15/12/2021
Actual
Date of last data collection
Anticipated
15/12/2022
Actual
Sample size
Target
600
Accrual to date
250
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 11714 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 11715 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 11716 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 11717 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 11718 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 12519 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [7] 12520 0
Camden Hospital - Camden
Recruitment hospital [8] 12521 0
Bowral Hospital - Bowral
Recruitment hospital [9] 12522 0
Fairfield Hospital - Prairiewood
Recruitment hospital [10] 12605 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [11] 12606 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [12] 12607 0
Hampstead Rehabilitation Centre - Northfield
Recruitment hospital [13] 12608 0
Peter James Centre - Forest Hill
Recruitment hospital [14] 12609 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [15] 12610 0
Wantirna Health - Wantirna
Recruitment hospital [16] 12611 0
Yarra Ranges Health - Lilydale
Recruitment hospital [17] 13184 0
Griffith Rehabilitation Hospital - Hove
Recruitment hospital [18] 17991 0
Westmead Hospital - Westmead
Recruitment hospital [19] 17992 0
Ryde Hospital - Eastwood
Recruitment hospital [20] 17993 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 23796 0
2170 - Liverpool
Recruitment postcode(s) [2] 23797 0
2200 - Bankstown
Recruitment postcode(s) [3] 23798 0
2050 - Camperdown
Recruitment postcode(s) [4] 23799 0
2031 - Randwick
Recruitment postcode(s) [5] 23800 0
2065 - St Leonards
Recruitment postcode(s) [6] 23808 0
4000 - Brisbane
Recruitment postcode(s) [7] 24900 0
2560 - Campbelltown
Recruitment postcode(s) [8] 24901 0
2570 - Camden
Recruitment postcode(s) [9] 24902 0
2576 - Bowral
Recruitment postcode(s) [10] 24903 0
2176 - Prairiewood
Recruitment postcode(s) [11] 24984 0
5042 - Bedford Park
Recruitment postcode(s) [12] 24985 0
5011 - Woodville
Recruitment postcode(s) [13] 24986 0
5085 - Northfield
Recruitment postcode(s) [14] 24987 0
3131 - Forest Hill
Recruitment postcode(s) [15] 24988 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [16] 24989 0
3152 - Wantirna
Recruitment postcode(s) [17] 24990 0
3140 - Lilydale
Recruitment postcode(s) [18] 25739 0
5048 - Hove
Recruitment postcode(s) [19] 31950 0
2145 - Westmead
Recruitment postcode(s) [20] 31951 0
2122 - Eastwood
Recruitment postcode(s) [21] 31952 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 300487 0
Government body
Name [1] 300487 0
National Health and Medical Research Council, Australia
Country [1] 300487 0
Australia
Primary sponsor type
University
Name
The University Of Sydney
Address
Institute for Musculoskeletal Health
School of Public Health
Faculty of Medicine and Health
Level 10 North, Building 13
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 299961 0
None
Name [1] 299961 0
Address [1] 299961 0
Country [1] 299961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301287 0
SLHD RPA Zone
Ethics committee address [1] 301287 0
Ethics committee country [1] 301287 0
Australia
Date submitted for ethics approval [1] 301287 0
11/07/2018
Approval date [1] 301287 0
22/08/2018
Ethics approval number [1] 301287 0
X18-0234

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86498 0
Prof Catherine Sherrington
Address 86498 0
Institute for Musculoskeletal Health
School of Public health
Faculty of Medicine and Health
Level 10 North, King George V Building,
Royal Prince Alfred Hospital (C39)
Camperdown NSW 2050
Country 86498 0
Australia
Phone 86498 0
+612 86276265
Fax 86498 0
+612 86276262
Email 86498 0
cathie.sherrington@sydney.edu.au
Contact person for public queries
Name 86499 0
Catherine Sherrington
Address 86499 0
Institute for Musculoskeletal Health
School of Public health
Faculty of Medicine and Health
Level 10 North, King George V Building,
Royal Prince Alfred Hospital (C39)
Camperdown NSW 2050
Country 86499 0
Australia
Phone 86499 0
+612 86276265
Fax 86499 0
+612 86276262
Email 86499 0
cathie.sherrington@sydney.edu.au
Contact person for scientific queries
Name 86500 0
Catherine Sherrington
Address 86500 0
Institute for Musculoskeletal Health School of Public Health Faculty of Medicine and Health Level 10 North, King George V Building, Royal Prince Alfred Hospital (C39) Camperdown NSW 2050
Country 86500 0
Australia
Phone 86500 0
+61286276265
Fax 86500 0
+61286276262
Email 86500 0
cathie.sherrington@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9701Study protocolhttps://protect-au.mimecast.com/s/AnGZCnx1jniB0L8Wi9BG92?domain=bmjopen.bmj.com  



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhysical activity coaching for adults with mobility limitations: Protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial.2020https://dx.doi.org/10.1136/bmjopen-2019-034696
N.B. These documents automatically identified may not have been verified by the study sponsor.