Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research

February 14, 2016 updated by: National Cheng-Kung University Hospital

The Health Effects of Cognitive Stimulation, Reminiscence, and Aroma-massage Complementary Interventions on Different Behavior Patterns of Patients With Dementia: Comparative and Longitudinal Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will base on the pattern of behavioral and psychological symptoms of dementia, to verify and compare the effectiveness of the three non-pharmacological complementary interventions, cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy on patients' cognitive function, behavior and psychological symptoms, and quality of life.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 701
        • National Cheng Kung University Dementia center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive stimulation
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

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.

Other Names:
  • Reminiscence complementary therapy
Experimental: Aroma-massage
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

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.
Experimental: reminiscence
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
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.
No Intervention: Control
Control group remain regular activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
behavioral and psychological symptoms of dementia
Time Frame: 2 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 2 years

To examine if patients' quality of life improve after the intervention. WHO Quality of Life-brief Taiwanese version (WHOQOL-BREF) will be used to measure this outcome.

Data will be analyzed through GLM-repeated measure-GEE.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Jing-Jy Wang, PhD, National Cheng Kung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 27, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sellin127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Reminiscence

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe