Clinical Trials Logo

Clinical Trial Summary

This intervention study is a part of the FOCUS (Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input) project which purpose is to critically reduce the burden of frailty in Europe by assisting those partners within the European Innovation Partnership for Active Healthy Ageing (EIPAHA) with commitments focusing on early diagnosis/ screening and/or management of frailty to achieve scalability.

FOCUS aims to critically reduce the burden of frailty in Europe by developing methodologies and tools to assist entities focusing on early diagnosis, screening and management of frailty to achieve scalability. Frailty is a common clinical syndrome in older adults that brings an increased risk for poor health outcomes including falls, incident disability, hospitalization and mortality.

The FOCUS Consortium brings together a multidisciplinary team of specialists from 10 organizations in 6 countries - Italy, Poland, Portugal, Spain, Netherlands, United Kingdom - that will work on developing, piloting and disseminating methodologies and tools to assist entities focusing on early diagnosis, screening and management of frailty to achieve scalability.

Wroclaw Medical University actively participates in all projects for the advances in science, entrepreneurship, technological innovation, both with public authorities, local governments, and enterprises. In FOCUS project, WMU is responsible for Evaluation of the project and collaborates with the others partners in Coordination of the project, Dissemination of the project, Synthesis of learning and realities of practice, Analysis and guidelines development, Creation of Network and Platform for knowledge exchange, Test of guidelines in a set of commitments (Work Package 7 - WP7).

The outcomes of this proposal will offer significant potential improvements for innovative, coordinated and comprehensive community based prevention with regard to the optimisation of functional capacity tools to address pre-frailty, and for improving the management of frailty.

The registered study has its own protocol developed by Wroclaw Medical University research team and will be implemented within WP7 of the FOCUS project.


Clinical Trial Description

This is a prospective intervention study. The study is expected screening about 320 participants - persons aged more than 60 years old recruited from Universities of the Third Age, day care centers, primary care centers, geriatrics out-patient clinics and from nursing homes. We are expected to enroll 270 potential participants (at least 135 participants) to 5 groups: 4 intervention groups and 1 control group without any intervention.

Patient qualification is based on criteria developed by Fried et al 2001.

Dimensions:

Weight loss Exhaustion Physical Activity Walk Time Grip Strength

INTERPRETATION:

Robust: 0 points Pre-frail: 1-2 points Frail: 3 or more points

Method: diagnostic survey Technique: the 'surveys combined with direct measurements of patients investigated within 0, after 3 and 6 months

Tools:

Study questionnaires:

• Standardized questionnaires: Center for Epidemiologic Studies Depression Scale Minnesota Leisure Time Physical Activity Questionnaire Vulnerable Elders — 13 Survey Mini Nutritional Assessment Health Behaviour Inventory Montreal Cognitive Assessment Geriatric Depression Scale World Health Organization Quality of Life (short version) questionnaire Camberwell Assessment of Need Short Appraisal Schedule Barthel Scale Activities of Daily Living Instrumental Activities of Daily Living Camberwell Assessment of Need Short Appraisal Schedule Timed up and go test Beck Depression Inventory

- The questionnaire on: socio-demographic data - age, gender, marital status, living in relationship/ without relationship, level of education, place of residence, economic status; the number of hospitalizations in the last 3 years (including kind of ward); the number and kind of chronic diseases (ICD-10); the number of permanent medications; employment situation; number of traveling in the last year; having pets; number of languages the participants can speak; number of falls

- Rating of patients' difficulties in the implementation of the intervention (Did the patients perform the interventions? How often? Was it difficult to the patients?)

- Observations sheet: height, weight, BMI, hand grip strength, circumference of arm muscle, circumference of calf

- The results of laboratory tests: sodium , albumins, lymphocytes, LDL cholesterol, C reactive proteins, glomerular filtration rate, fasting glucose, thyroid hormones ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03194412
Study type Interventional
Source Wroclaw Medical University
Contact
Status Active, not recruiting
Phase N/A
Start date May 19, 2017
Completion date December 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04992286 - Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING) N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04061785 - Impact of Skills Acquired Through Judo Training on Risk Factors for Falling in Elderly Men and Women N/A
Completed NCT04140890 - Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study N/A
Recruiting NCT03141866 - Seated Physical Activity in Ageing N/A
Completed NCT04888884 - Loss of Independence - a Rapid Alternative to Frailty Screening in a Swedish ED Setting
Recruiting NCT04145726 - Frailty In Thoracic Surgery for Esophageal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Not yet recruiting NCT06022666 - PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery. N/A
Not yet recruiting NCT06042244 - Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis N/A
Not yet recruiting NCT04514536 - Evaluation of a Health Monitoring Platform for Elderly in Home Care Context N/A
Completed NCT01126723 - Effects of Tai Chi on Frailty in Elderly Adults N/A
Completed NCT00183040 - HORMA: Hormonal Regulators of Muscle and Metabolism in Aging Phase 2
Recruiting NCT05961319 - Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
Enrolling by invitation NCT05047731 - Antihypertensive Deprescribing in Long-term Care N/A
Completed NCT04956705 - Vitamin D and Calcium Supplementation at Danish Nursing Homes N/A
Recruiting NCT03824106 - Frailty Rehabilitation Phase 4
Recruiting NCT04518423 - Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People