NCT04311138

Brief Summary

This study aims o investigate the effect of a diversified community-based reablement on motor function, cognitive function, performance in activities of daily living (ADL), and physical performance of older people living in remote areas. Older adults who are mobile but unstable were recruited from 6 public elderly day care centers in remote areas of the New Taipei City. Experimental group received a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour, while control group received 1.5-hr group intervention and 1.0-hr placebo intervention. The de Morton Mobility Index (DEMMI), Saint Louis Mental Status Examination (SLUMS), Barthel Index (BI), Canadian Occupational Performance Measure (COPM), and the Short Physical Performance Battery (SPPB) including balance, gait speed, chair stand tests were evaluated twice before and after interventions. The results of the current study are expected to provide evidence in supporting a novel and diversified community-based reablement in remote areas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 12, 2020

Last Update Submit

March 14, 2020

Conditions

Keywords

reablementcommunity

Outcome Measures

Primary Outcomes (5)

  • Change in mobility function

    de Morton Mobility Index (DEMMI)

    baseline and 10 weeks

  • Change in cognitive function

    Saint Louis Mental Status Examination (SLUMS)

    baseline and 10 weeks

  • Change in performance in activities of daily living

    Barthel Index (BI)

    baseline and 10 weeks

  • Change in occupational performance

    Canadian Occupational Performance Measure (COPM)

    baseline and 10 weeks

  • Change in physical performance

    Short Physical Performance Battery (SPPB)

    baseline and 10 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group receive a 10-wk diversified community-based reablement service.

Other: community-based reablement service

Control group

ACTIVE COMPARATOR

Control group receive a 10-wk multicomponent training.

Other: multicomponent training

Interventions

Experimental group receive a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour.

Experimental group

control group receive a 10-wk multicomponent training including 1.5-hr group intervention (group exercise, cognitive training, and health education) and 1.0-hr placebo intervention.

Control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • living in community and participating in public elderly day care centers in remote areas of the New Taipei City
  • speaking with Chinese or Taiwanese
  • DEMMI score of 39-67

You may not qualify if:

  • diagnosed with moderate or severe cognitive impairment (CDR score of 2 or above)
  • unable to understand or follow one step instruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 11219, Taiwan

Location

Study Officials

  • ChenYi Song

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 17, 2020

Study Start

September 3, 2019

Primary Completion

November 29, 2019

Study Completion

November 29, 2019

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations