Timeline for the AMBER Study

Ethics approval granted 11th June 2014
Funded started July 2014

Month 3 milestones (1st October 2015)

  • Protocol for trial developed and finalised. Contracts are signed by the Chief Investigator and co-applicants.
  • Setting up of trial office and administrative base, start design of study database and randomisation system.
  • Design and develop Clinician’s handbook, patient documentation, abdominal massage training DVD videos for patients/carers and staff.
  • Recruitment of sites. Upon receiving ethical approval at individual sites, training visits by the Chief Investigator take place and local recruiters and intervention nurses are appointed at every site.  
  • Advertise and hire additional staff members: trial manager, trial coordinator and process evaluation researcher.

By month 6 (1st January 2015)

  • The Data Monitoring Committee and the Steering Committee hold their first meetings. 
  • Start recruitment at first two sites.
  • Recruitment and training of sites continues.

By month 10 (1st May 2015)

  • Recruitment and training of sites continues.
  • Interviews with healthcare professionals and patients.
  • Collaborators hold a meeting.

By month 12 (1st July 2015)

  • First annual report submitted to funders. 
  • 10 sites should be up and running. More sites to come on board depending on recruitment.
  • Patients continue to be recruited into trial and randomised to intervention (abdominal massage) or control groups (advice only).
  • Interviews with healthcare professionals and patients.

By month 18: (1st Jan 2016)

  • Patients continue to be recruited into trial and randomised to intervention (abdominal massage) or control groups (advice only).
  • Interviews with healthcare professionals and patients.
  • The Data Monitoring Committee and the Steering Committee hold their second meetings.

By month 24: (1st July 2016)

  • Recruitment into trial complete.
  • Patients continue to be enrolled in the trial and randomised to intervention or control groups. 
  • Interviews with healthcare professionals and patients continue. 
  • Second annual report is submitted to funders.

By month 26: (1st September 2016)

  • Interviews with healthcare professionals, patients and stakeholders continue.
  • The Data Monitoring Committee and the Steering Committee hold their third meetings.

By month 30: (1st January 2017)

  • Questionnaire follow up at 6 months post randomisation completed. Interviews with healthcare professionals, patients and stakeholders completed.

By month 36: (1st July 2017)

  • Final Trial Steering Committee and Collaborators meetings.
  • Data analysis completed. 
  • Data archiving arrangements put in place.

By month 39: (1st October 2017)

  • Post funding Final report from trial.
  • Dissemination of results (papers).