Community-based Rehabilitation Management for Patients With Remitted Geriatric Depression

NCT05610917 | Unknown Early Phase 1 DMC

• 1 other identifier: ChengdeMU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to take patients with RGD as objects. Further construct a community-based rehabilitation management (CBRM) program with drug treatment, rehabilitation measures of education, psychology and exercise as its core content on the basis of evidence-based practice approach. Based on the cost-utility analysis of health economics, the health and economic benefits of the CBRM program will be evaluated, and a theoretical reference will be provided for community health institutions to carry out whole-course rehabilitation management practice and health policy formulation.

Conditions

Geriatric Depression

Keywords

Remitted geriatric depression; Physio-cognitive decline syndrome; risk early warning mechanism; community-based rehabilitation management

Outcome Measures

Primary Outcomes (4)

• depressive symptoms

  The Hamilton Depressive Scale (HAMD-17) which consists of 17 items will be employed to screen for depressive symptoms and evaluate the mental status and severity of depressive symptoms. Scores were calculated by totaling the responses, which can be divided into four types (Health): normal/not depressed (0-7 points), mild/subthreshold (8-13), moderate/mild (14-18), severe/moderate (19-22), and severe/very severe (\>23).

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

• cognitive and intellectual function

  Mini-mental State Examination (MMSE), as a simple screening tool for cognitive and intellectual function decline in the elderly with a total score of 30. The results of this test is closely related to the level of education, and the normal cutoff is defined as, illiterates \>17 points, primary schools \>20 points, and middle schools and above \>24 points.

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

• changes of the handgrip strength

  The grip strength of a man's dominant hand \< 28kg or a woman \< 18kg is considered to have weak grip strength. The grip strength increased compared with the baseline period, that is, the subjects' physiological function tended to recover; Instead, physiological function tends to decline.

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

• changes of the gait speed

  The time it takes for the subject to walk 6 meters at normal pace from the starting point without slowing down, with a threshold for gait deceleration set to \< 1m/s. The gait speed increased compared with the baseline period, that is, the subjects' physiological function tended to recover; Instead, physiological function tends to decline.

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

Secondary Outcomes (10)

• quality of life of the elderly

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

• sleep quality

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

• the balance ability of the elderly

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

• activity of daily living

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

• the word memory function

  This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.

Study Arms (2)

case group,

EXPERIMENTAL

Patients in case group will be treated with CBRM program

Combination Product: CBRM (community-based rehabilitation management)

control group

OTHER

the control group patients will be treated routinely as usual.

Combination Product: TAR(treatment as routine)

Interventions

CBRM (community-based rehabilitation management) COMBINATION_PRODUCT

The case group patients will undergo drug treatment (Selective Serotonin Reuptake Inhibitors), health education, cognitive-motor dual task training, cognitive-training.

case group,

TAR(treatment as routine) COMBINATION_PRODUCT

Patients in control group will be treated rountinely which includes drug treatment (SSRIs) and traditional health education.

control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 60 years old or above at the time of enrollment;
• meet the diagnostic criteria for MDD without psychotic features according to DSM-5, and depressive symptoms have been improved and remained stable for at least 2 months after treatment with SSRIs;
• the total score of HAMD-17 is less than 7 at the time of enrollment;
• meet the diagnostic criteria for physio-cognitive decline: 1) the total score of ADL and IADL was less than 26; 2)cognitve decline: first, subjects with severe impairment of cognitive function will be excluded (years of education ≥ 6, MMSE scores \<24；years of education \<6 years, MMSE total score \<14). After completing a neuropsychological task, cogintive declined will be confirmed when any aspects of cognitve function is 1.5 standard deviations lower than that of normal elderly; 3) the grip strength is weakened, and the domaint hand grip strength is \< 28kg for males or \<18kg for females; 4)slow step speed, that is, in a space of length \>10 meters, the subjects walks 6 meters from the starting point at a normal and uniform pace, and the pace is \<1m/s.
• comprehension, reading and writing skills to complete the measurements or complete them with assistance of the researchers with obstacles;
• voluntary participation and signed informed consent.

You may not qualify if:

• meet the diagnostic of schizophrenia, bipolar disorder, dementia;
• comorbidity of physical diseases, such ascardiovascular and cerebrovascular diseases, rheumatoid arthritis, stroke and malignant tumors;
• history of alcohol or drug dependence;
• severe deformity of spine and limbs;
• complete or partial dependence on caregivers for daily life, such as long-term bedridden, wheelchair assisted;
• have received physical therapy or psychological treatment in the past three months;
• currently participating in other clinical research.

Sponsors & Collaborators

• Duan Li: lead

Study Sites (1)

Chengde Medical University

Chengde, Hebei, 067000, China

Location

Related Publications (6)

• Chen LK, Arai H. Physio-cognitive decline as the accelerated aging phenotype. Arch Gerontol Geriatr. 2020 May-Jun;88:104051. doi: 10.1016/j.archger.2020.104051. Epub 2020 Apr 4. No abstract available.

  PMID: 32278485 RESULT

• Liu LK, Chou KH, Hsu CH, Peng LN, Lee WJ, Chen WT, Lin CP, Chung CP, Wang PN, Chen LK. Cerebellar-limbic neurocircuit is the novel biosignature of physio-cognitive decline syndrome. Aging (Albany NY). 2020 Nov 25;12(24):25319-25336. doi: 10.18632/aging.104135. Epub 2020 Nov 25.

  PMID: 33234736 RESULT

• Liang CK, Lee WJ, Hwang AC, Lin CS, Chou MY, Peng LN, Lin MH, Chen LK. Efficacy of Multidomain Intervention Against Physio-cognitive Decline Syndrome: A Cluster-randomized Trial. Arch Gerontol Geriatr. 2021 Jul-Aug;95:104392. doi: 10.1016/j.archger.2021.104392. Epub 2021 Mar 13.

  PMID: 33765656 RESULT

• Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

  PMID: 25771249 RESULT

• Chen LK, Hwang AC, Lee WJ, Peng LN, Lin MH, Neil DL, Shih SF, Loh CH, Chiou ST; Taiwan Health Promotion Intervention Study for Elders research group. Efficacy of multidomain interventions to improve physical frailty, depression and cognition: data from cluster-randomized controlled trials. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):650-662. doi: 10.1002/jcsm.12534. Epub 2020 Mar 5.

  PMID: 32134208 RESULT

• Merchant RA, Chan YH, Hui RJY, Tsoi CT, Kwek SC, Tan WM, Lim JY, Sandrasageran S, Wong BLL, Chen MZ, Ng SE, Morley JE. Motoric cognitive risk syndrome, physio-cognitive decline syndrome, cognitive frailty and reversibility with dual-task exercise. Exp Gerontol. 2021 Jul 15;150:111362. doi: 10.1016/j.exger.2021.111362. Epub 2021 Apr 19.

  PMID: 33887381 RESULT

Study Officials

• Li Duan, Dr.

  Chengde Medical University

  STUDY DIRECTOR

Central Study Contacts

Li Duan, Dr.

CONTACT

86-13831425750; dfhedianren@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor Duan

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 9, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)