Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial-INTERCOG study.
Diana Carolina Tiga-Loza, William Armando Álvarez-Anaya, Raquel Rivera-Carvajal, Ariel Calderón Ardila, Jhosman Alfonso Buitrago-Buitrago, Alexander Pabon, Álvaro Castañeda-Hernández, Mabel Margoth Reyes-Pulido, Katherine Prado Guzmán, Hadder Uriel Acosta Salazar, Edwing Alberto Urrea-Vega, Lina María Carreño-Parra, Paul Anthony Camacho
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引用次数: 0
Abstract
Background: Given the risk of progression to dementia ranging from 6 to 44.8% over approximately 4 years of follow-up, nonpharmacological multicomponent interventions are emerging as promising strategies to improve or maintain cognitive function and quality of life in individuals with mild cognitive impairment (MCI). This pilot study aims to evaluate the feasibility and potential efficacy of a multicomponent and transdisciplinary intervention focused on the dyad of older adults with MCI-family study partner to promote cognitive function in older adults.
Methods: A pilot, randomized, controlled, and double-blind clinical trial will be conducted with 102 dyads consisting of an older adult with MCI and their family study partner. The participants will be randomly assigned to two groups: the intervention group (INTERCOG) and the control group. The INTERCOG group will receive a 12-week home-based intervention (twice weekly) with the support of a healthcare professional. The intervention components consist of cognitive training and stimulation, nutritional counseling, and physical exercises. Simultaneously, family members will participate in a training program on care and self-care. The control group will receive an Enhanced Standard of Care with educational messages on infection prevention. The feasibility of the study will be assessed through an analysis of recruitment, data collection, intervention acceptability, and implementation challenges; also, changes in global cognition and changes in specific cognitive domains will be measured as exploratory results. Secondary outcomes will include changes in health-related quality of life, caregiver burden, social support for family members, as well as changes in functional independence, frailty, physical capacity, family functioning, and nutritional status in patients, with follow-up at 3, 6, and 9 months. In a subsample of 40 participants, the diversity of the gut microbiota will be characterized, and the frequency of the APOE-ε4 allele will be determined.
Discussion: Multicomponent and transdisciplinary interventions focused on the family member-patient dyad have the potential to optimize cognitive outcomes and quality of life. This pilot study will allow us to identify key aspects of the feasibility and potential efficacy of INTERCOG intervention, crucial information for the design of future larger-scale studies.
Trial registration: NCT06408103. December 6, 2024, at clinicaltrials.gov. In recruitment.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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