Table 1

CARE75+ study pathways

CARE75+CARE75+ REMOTECARE75+2
Recruitment startDecember 2014May 2021Anticipated start April 2022
Recruitment endMarch 2020September 2024
Recruitment target2500 across all CARE75+ study pathways by September 2024
Recruitment to date1323140
Study statusNo new recruitment on this pathway. Follow-ups in progressOn-going with recruitment and follow-ups underwayNot started. REC approval in place
ConsentIn person, at the participant’s homeTelephone (audio-recorded) or postalIn person, at the participant’s home
In person, at a general practice location
Assessment formatIn person, at the participant’s home, apart from at 6 months where there is the option of a modified protocol by telephone or web submission.Postal questionnaire, web submission or by telephone
If there is deterioration in the participant’s health, hearing or vision, or cognition, during the course of the study, which makes the above formats problematic, face-to-face assessments will be undertaken if safe and feasible.
In person at baseline, 12 months and 24 months
intermediate and final assessments (6, 18, 30 and 36 months) will be conducted by telephone, postal or web submission
Option for in-person assessments to take place at a general practice location.
Assessment time pointsBaseline, 6, 12, 24, 48 monthsBaseline, 6, 12, 18, 24, 30, 36 monthsBaseline, 6, 12, 18, 24, 30, 36 months
Outcome domains included across all study pathwaysSociodemographic data
Frailty
Health-related quality of life
Activities of daily living
Depression
Cognition
Comorbidities (GP)
Medication (GP)
Additional outcome domains for specific CARE75+pathwaysMobility
Muscle strength
Pain
Hearing
Vision
Loneliness
Resilience
Self-efficacy
Falls
Blood pressure
Sedentary behaviour
Feeling safe in your neighbourhood
Anxiety
Informal care
Healthcare and social care use
Aids and adaptations
Mobility
Physical performance
Hearing (satisfaction with hearing aids)
Vision
Anxiety
Informal care
Healthcare and social care use
Aids and adaptations
Loneliness
Social isolation
Social networks
Resilience
Self-efficacy
Caring responsibilities
Carer’s quality of life (if applicable)
Nutrition
Dental health
Access to the internet
Feeling safe in your neighbourhood
Blood samplesYes (limited sites only)NoYes (limited sites only)
NotesDue to the impact of COVID-19, face-to-face follow-up assessments moved to telephone assessments until June 2021 when face-to-face visits were able to resume with specific safety measures in place, and depending on guidance by individual NHS trusts and the research capacity within individual Clinical Research Network organisations.CARE75+ REMOTE and CARE75+2 study arms will run concurrently.
Participants who start on one study pathway will remain on that pathway.
  • CARE75+, Community Ageing Research 75+ ; GP, General Practice; NHS, National Health Service; REC, Research Ethics Committee.