Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes

Frail Elderly Syndrome Clinical Trial

— POSTSCRIPTUM  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05740436
• Other study ID #: 2021/GR
• Status: Active, not recruiting
• Start date: August 21, 2021
• Est. completion date: August 2023

Study information

• Verified date: February 2023
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Frail Elderly Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Russian Federation	Russian Research and Clinical Center for Gerontology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional status dynamics	Instrumental Activity Daily Life scale score	13 months