Design
BLIND, STILL
A mixed-methods parallel randomised controlled trial design with an equal randomisation ratio, stratified based on level of frailty, was conducted. No sample size calculation was performed for this trial. Still, it was estimated that 160 people with frailty would be included based on the resource available and the number of registered patients at two participating GP centres. Those eligible completed the study outcome assessment form and subsequently were randomised to either CGA & CSP or treatment as usual (TAU) care using a web-based randomiser available at randomizer.org by a research assistant. The intervention group received the CGA & CSP for six months, which included an interim (3 months) and a final (6 months) review. Data were collected 2–3 weeks prior to the start of the intervention and again 2–3 weeks after final review. Professionals delivering the intervention to participants were masked to baseline and follow-up measurements. Outcome assessors were also blind to group allocation. A protocol was published a priori at clinicaltirals.gov ID: NCT03394534 on 09/01/2018. To ensure the quality of reporting, the Consolidated Standards of Reporting Trials (CONSORT), an extension to randomised pilot and feasibility trials (2010), was followed.