Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research

Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126059
• Other study ID #: Sellin127
• Status: Completed
• Phase: N/A
• First received: April 21, 2014
• Last updated: February 14, 2016
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Dementia center	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	quality of life	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	Yes