ClinicalTrials.gov
ClinicalTrials.gov Menu

Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02126059
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Reminiscence Behavioral: Cognitive stimulation Behavioral: Aroma-massage Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: The Health Effects of Cognitive Stimulation, Reminiscence, and Aroma-massage Complementary Interventions on Different Behavior Patterns of Patients With Dementia: Comparative and Longitudinal Research
Study Start Date : January 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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 Name: 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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126059


Locations
Taiwan
National Cheng Kung University Dementia center
Tainan, Taiwan, 701
Sponsors and Collaborators
National Cheng-Kung University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Jing-Jy Wang, PhD National Cheng Kung University

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02126059     History of Changes
Other Study ID Numbers: Sellin127
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by National Cheng-Kung University Hospital:
dementia
behavioral and psychological symptoms
quality of life

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders