Clinical trial NCT05740436: Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly Syndrome
Keywords: geriatric rehabilitation
elderly
frailty
Complex geriatric assessment
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 420
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men and women aged 60 years and older eligible for geriatric rehabilitation, who were addmited to one of the study sites

Brief summary: After screening complex geriatric assessment (CGA) the participants will undergo geriatric rehabilitation programs. After termination of 21-day program, CGA will be repeated and subjects will get a program of long-term rehabilitation. A phone call in six months and a face-to-face visit in 12 months will be scheduled to follow-up and to evaluate the progress in rehabilitation.

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.

Eligibility criteria: Inclusion Criteria:

1. Men and women aged 60 and older who wanted to participate in the study and signed a consent form.
2. 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:

1. One or more contraindications to geriatric rehabilitation:

   1. Severe sensory and cognitive impairment hampering rehabilitation
   2. End stage diseases requiring palliative care
   3. End stage frailty (bedridden patients)
2. An acute illness or an exacerbation of a chronic disease during two weeks before the enrollment in the study
3. A contradiction to any component of a rehabilitation program
4. Hearing or visual lost that can influence on study tests results
5. Refuse to participate in the study -

Primary outcomes:
measure: functional status dynamics
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Research and Clinical Center for Gerontology
Study officials:
affiliation: - Pirogov Russian National Research Medical University, the Russian Research and Clinical Center for Gerontology
name: Olga N Tkacheva, Dr.
role: PRINCIPAL_INVESTIGATOR
References: