The WHO defined 6 key functions that people value most, including mobility, cognition, nutrition/vitality, mental health, vision and hearing, which as a composite outcome define intrinsic capacity. To monitor and strengthen intrinsic capacity, the WHO established the ICOPE, which has been increasingly adopted by researchers and clinicians as function captured by ICOPE has been found to predict current and future health states, as well as future care need in support of activities of daily living. While feasibility studies on ICOPE have been implemented in several countries, clinical efficacy of the program has yet to be established in a randomized controlled trial.
Composite primary outcome intrinsic capacity:
The DO-HEALTH team and consortium partner Prof. E. John Orav defined a composite primary endpoint reflecting 6 components of function, one in each of the 6 ICOPE function domains. This fits with the personalized ICOPE intervention tested in our trial. For each component of function, a standardized effect for each subject will be calculated over 6 months (for the pilot). The composite primary endpoint for each subject is then the average across the 6 standardized functional component effects. With this concept, a participant can achieve a standardized improvement of 0.15 by having a small standardized improvement of 0.15 on each of the 6 components; or by having a large improvement of 0.90 on one component and no improvement on any of the other 5 components. In this way, different participants can benefit in different ways from the intervention.
Pilot trial:
The ICOPE-pilot trial is a 2-arm, 6-month randomized-controlled-trial among 100 adults aged 70 years and older living independently in the community. As part of the screening process, candidates will be assessed in all 6 functional domains: mobility, cognition, nutrition/vitality, vision, hearing and mental health. To participate, a candidate must experience impairment in at least two of the ICOPE functional domains confirmed by the ICOPE screening nurse. In the intervention group (n = 50), participants will receive the ICOPE intervention program personalized to the six ICOPE domains and based on the WHO ICOPE handbook applied by trained ICOPE nurses. Participants will be reassessed after 6 months of the intervention. In addition, a phone-based follow-up at 12 months to evaluate ICOPE functions and extended adherence to the intervention. In the control group, participants will receive only standard of care by the family doctor. Key secondary outcomes biology of aging: Next to additional outcomes on muscle, brain and immune health (to align with XPRIZE concept), the trial partners with the Harvard Longevity Study regarding the measurement of its omics biomarker of aging battery assessed before and after the ICOPE-based intervention and collaborating with the Vadim Gladyshev laboratory Division of Harvard Medical Sciences.