NCT02126059

Brief Summary

Cognitive function, behavioral and psychological symptoms, and quality of life will improve after administration of cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy in patients with dementia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

April 21, 2014

Last Update Submit

February 14, 2016

Conditions

Keywords

dementiabehavioral and psychological symptomsquality of life

Outcome Measures

Primary Outcomes (1)

  • behavioral and psychological symptoms of dementia

    To examine if patients' behavioral and psychological symptoms decrease after the intervention. Chinese version of Cohen-Mansfield Agitation Inventory (CMAI) will be used to measure this outcome. Data will be analyzed through GLM repeated measure-GEE.

    2 years

Secondary Outcomes (1)

  • quality of life

    2 years

Study Arms (4)

Cognitive stimulation

EXPERIMENTAL

One cognitive stimulation session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to cognitive stimulation.

Behavioral: Reminiscence

Aroma-massage

EXPERIMENTAL

One hand and shoulder massage session per week for a continuous 10 weeks, each session contains 30 minutes, totally 10 session massage.

Behavioral: Cognitive stimulation

reminiscence

EXPERIMENTAL

One reminiscence session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to reminiscence.

Behavioral: Aroma-massage

Control

NO INTERVENTION

Control group remain regular activities

Interventions

ReminiscenceBEHAVIORAL

The 10 session topics include "Happy to seeing you", "Childhood stories", "Food flavor", "Our old songs", "Festival", "My family", "My Carrier", "Unforgettable events", "My home", and "My award". small group intervention (8-12 per group), expected total number of group is 5.

Also known as: Reminiscence complementary therapy
Cognitive stimulation

The 10 session topics include "psycial activities", "sound", "face", "food", "word association", "number and games", "being creative", "categorizing objects", "orientation", and "team qiuz". small group intervention (8-12 per group), total number of group is 5.

Aroma-massage
Aroma-massageBEHAVIORAL

Researcher will conduct hand and arm massage to a patient, once a week, each time session for 30 mins with natural tested and safe aroma-essential oil.

reminiscence

Eligibility Criteria

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

You may qualify if:

  • been diagnosed with dementia (all stages) or MMSE below 23 for high school educated and 17 for less than high school education
  • able to communicate verbally or nonverbally
  • able to understand short sentences
  • can sit for at least 50 mins.

You may not qualify if:

  • no hospitalization within the past two weeks
  • not under severe acute illness
  • no psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Dementia center

Tainan, 701, Taiwan

Location

Related Publications (1)

  • Ball EL, Owen-Booth B, Gray A, Shenkin SD, Hewitt J, McCleery J. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020 Aug 19;8(8):CD003150. doi: 10.1002/14651858.CD003150.pub3.

MeSH Terms

Conditions

DementiaBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jing-Jy Wang, PhD

    National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 29, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations