- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05740436
Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes (POSTSCRIPTUM)
POSTSCRIPTUM: Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes. Protocol of Multicentral Prospective Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After screening complex geriatric assessment (CGA) the participants will undergo geriatric rehabilitation programs. The participation duration will not exceed 13.5 months including the screening period.
The study comprises three periods:
- screening (1-14 days)
- a treatment course of 21 days
- a follow-up period of 12 months On screening visit Study procedures will include
- Informed consent signing
- The Comprehensive Geriatric Assessment (CGA)
- The recommendations on a program of geriatric rehabilitation based on CGA
Visit 2 will be performed at the end of rehabilitation program. It will include:
- The abbreviated CGA
- The evaluation of the results of 21-days geriatric rehabilitation program
- The recommendations on a long-term geriatric rehabilitation
Visit 3 will be scheduled in 3 months after Visit 2 as a phone call. Special questionnaire will be suggested to study subjects. The questionnaire includes questions on implementation of a geriatric rehabilitation program and on quality of life
Visit 4- the last study visit will be performed in 12 months after Visit 2. It will include CGA and study completion procedures.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Moscow, Russian Federation, 129226
- Russian Research and Clinical Center for Gerontology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men and women aged 60 and older who wanted to participate in the study and signed a consent form.
One or more indications for geriatric rehabilitation:
- A discharge after a hospitalization due to an acute illness (excluding stroke and myocardial infarction), trauma, surgery, including planned ones.
- A condition leading to an acute impairment of functional status (stress, etc.)
- Newly admitted patients
- Abnormalities of gait and mobility (R26)
Exclusion Criteria:
One or more contraindications to geriatric rehabilitation:
- Severe sensory and cognitive impairment hampering rehabilitation
- End stage diseases requiring palliative care
- End stage frailty (bedridden patients)
- An acute illness or an exacerbation of a chronic disease during two weeks before the enrollment in the study
- A contradiction to any component of a rehabilitation program
- Hearing or visual lost that can influence on study tests results
- Refuse to participate in the study -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Frail elderly subjects
Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA
|
Geriatric rehabilitation program based on CGA will be performed under physicians tight control for 21 days and will include physical activity, psychological training, diet correction, adaptation measures, polypragmasia correction.
|
|
Pre-Frail elderly subjects
Pre-Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA
|
Geriatric rehabilitation program based on CGA will be performed under physicians tight control for 21 days and will include physical activity, psychological training, diet correction, adaptation measures, polypragmasia correction.
|
|
Non-frail elderly Frail subjects
Non-frail Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA
|
Geriatric rehabilitation program based on CGA will be performed under physicians tight control for 21 days and will include physical activity, psychological training, diet correction, adaptation measures, polypragmasia correction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional status dynamics
Time Frame: 13 months
|
Instrumental Activity Daily Life scale score
|
13 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Olga N Tkacheva, Dr., - Pirogov Russian National Research Medical University, the Russian Research and Clinical Center for Gerontology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021/GR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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