Creating Physical Objects With 3D Printers to Stimulate Reminiscing for Memory Loss [2 R44 AG049548-02A1]

NCT03625973 | Unknown DMC

• 1 other identifier: MoaiTech
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

In 2013 an estimated 5 million people age 65 and older had Alzheimer's disease. Longer life spans and aging baby boomers will cause this number to grow rapidly. More than 50% of residents in assisted living and nursing homes have some form of dementia or cognitive impairment and the number is increasing every day. As a form of person-centered, non-pharmacological dementia care, Reminiscence Therapy (RT) holds considerable promise. Improvements in mood, quality of life, social interaction, cognition, memory and a reduction in caregiver stress have been noted. This project will develop an operational model for identifying and producing 3D personal objects using 3D printing technology, and deploying them for use in RT. The research also will evaluate the effectiveness of using 3D-printed objects in RT compared to other types of memory stimuli. This novel approach to the "personalization" of reminiscence therapy will result in better social and mental health outcomes for individuals with dementia.

Conditions

Dementia

Keywords

Dementia; Memory, Episodic; Printing, Three-Dimensional

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive stimulation/reminiscence

  The Autobiographical Memory Interview (AMI) will be completed with PWMLs, a well-established method for assessing autobiographical memory (Kopelman, Wilson, Baddeley, 1989). Specifically, the AMI assesses the extent to which the PWML can recall memories related to factual, incident-specific information from their past. Higher scores indicate greater memory function. An audio recording will be made of the sessions. Later, a written verbal protocol record of each memory produced in the test session will be made from the audio recordings. These verbal protocol records each will be scored independently by two of our researchers. Scoring will be for richness and detail of the reminiscence and will follow the scoring guidelines provided in Kopelman, Wilson, and Baddeley \[10\]. Inter-rater reliability will be computed. Note that only one measure or score of reminiscence results from the AMI.

  Will be administered at Week 0 (prior to first therapy session) to establish a baseline. Measures at Week 8 (midpoint of therapy sessions), and Week 16 (following last therapy session) will determine change from the baseline.

Secondary Outcomes (6)

• Change in Dementia severity-SLUMS

  Will be administered at Week 0 (prior to first therapy session) to establish a baseline. Measures at Week 8 (midpoint of therapy sessions), and Week 16 (following last therapy session) will determine change from the baseline.

• Change in Dementia severity-Frequency of Behavioral Problems

  Will be administered at Week 0 (prior to first therapy session) to establish a baseline. Measures at Week 8 (midpoint of therapy sessions), and Week 16 (following last therapy session) will determine change from the baseline.

• Change in Dementia severity-dependence on assistance

  Will be administered at Week 0 (prior to first therapy session) to establish a baseline. Measures at Week 8 (midpoint of therapy sessions), and Week 16 (following last therapy session) will determine change from the baseline.

• Change in Social engagement

  Will be administered at Week 0 (prior to first therapy session) to establish a baseline. Measures at Week 8 (midpoint of therapy sessions), and Week 16 (following last therapy session) will determine change from the baseline.

• Change in Mood

  Will be administered at Week 0 (prior to first therapy session) to establish a baseline. Measures at Week 8 (midpoint of therapy sessions), and Week 16 (following last therapy session) will determine change from the baseline.

Other Outcomes (1)

• Functionality and usability of 3D printing mobile tools and paradigm for RT

  Interviews will be conducted at 16 weeks

Study Arms (3)

16 Weeks of 3D-RT

EXPERIMENTAL

Participants will receive 16 weeks of Reminiscence Therapy using 3D printed objects as stimuli.

Behavioral: 3D-RT

8 Weeks of 3D-RT

EXPERIMENTAL

Participants will receive 8weeks of Reminiscence Therapy using 3D printed objects as stimuli and 8 weeks of RT using verbal stimuli.

Behavioral: 3D-RT

16 Weeks of RT using Verbal Stimuli

ACTIVE COMPARATOR

Participants will receive 16 weeks of RT using verbal stimuli to reminiscence.

Behavioral: RT-Verbal

Interventions

3D-RT BEHAVIORAL

Objects printed using 3D printing media will be used as stimuli in Reminiscence Therapy

16 Weeks of 3D-RT; 8 Weeks of 3D-RT

RT-Verbal BEHAVIORAL

Verbal cues will be used as stimuli in Reminiscence Therapy

16 Weeks of RT using Verbal Stimuli

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Physician diagnosis of early-stage Alzheimer's disease or mild cognitive impairment
• Score of 10 or above on the brief St. Louis University Mental Status examination (SLUMS).

Sponsors & Collaborators

• Moai Technologies LLC: lead
• St. Louis University: collaborator
• The University of Texas at Arlington: collaborator

Study Sites (2)

Saint Louis University

St Louis, Missouri, 63103-1021, United States

RECRUITING

University of Texas Arlington

Arlington, Texas, 76019, United States

RECRUITING

Related Publications (12)

• Garlinghouse A, Rud S, Johnson K, Plocher T, Klassen D, Havey T, Gaugler JE. Creating objects with 3D printers to stimulate reminiscence in memory loss: A mixed-method feasibility study. Inform Health Soc Care. 2018 Dec;43(4):362-378. doi: 10.1080/17538157.2017.1290640. Epub 2017 Aug 8.

  PMID: 28786714 BACKGROUND

• Woods B, Spector A, Jones C, Orrell M, Davies S. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001120. doi: 10.1002/14651858.CD001120.pub2.

  PMID: 15846613 BACKGROUND

• Subramaniam P, Woods B. The impact of individual reminiscence therapy for people with dementia: systematic review. Expert Rev Neurother. 2012 May;12(5):545-55. doi: 10.1586/ern.12.35.

  PMID: 22550983 BACKGROUND

• Kopelman MD, Wilson BA, Baddeley AD. The autobiographical memory interview: a new assessment of autobiographical and personal semantic memory in amnesic patients. J Clin Exp Neuropsychol. 1989 Oct;11(5):724-44. doi: 10.1080/01688638908400928.

  PMID: 2808661 BACKGROUND

• Tariq SH, Tumosa N, Chibnall JT, Perry MH 3rd, Morley JE. Comparison of the Saint Louis University mental status examination and the mini-mental state examination for detecting dementia and mild neurocognitive disorder--a pilot study. Am J Geriatr Psychiatry. 2006 Nov;14(11):900-10. doi: 10.1097/01.JGP.0000221510.33817.86.

  PMID: 17068312 BACKGROUND

• Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of behavioral problems in dementia: the revised memory and behavior problems checklist. Psychol Aging. 1992 Dec;7(4):622-31. doi: 10.1037//0882-7974.7.4.622.

  PMID: 1466831 BACKGROUND

• Logsdon RG, Teri L. The Pleasant Events Schedule-AD: psychometric properties and relationship to depression and cognition in Alzheimer's disease patients. Gerontologist. 1997 Feb;37(1):40-5. doi: 10.1093/geront/37.1.40.

  PMID: 9046704 BACKGROUND

• van Marwijk HW, Wallace P, de Bock GH, Hermans J, Kaptein AA, Mulder JD. Evaluation of the feasibility, reliability and diagnostic value of shortened versions of the geriatric depression scale. Br J Gen Pract. 1995 Apr;45(393):195-9.

  PMID: 7612321 BACKGROUND

• Brod M, Stewart AL, Sands L, Walton P. Conceptualization and measurement of quality of life in dementia: the dementia quality of life instrument (DQoL). Gerontologist. 1999 Feb;39(1):25-35. doi: 10.1093/geront/39.1.25.

  PMID: 10028768 BACKGROUND

• Cotelli M, Manenti R, Zanetti O. Reminiscence therapy in dementia: a review. Maturitas. 2012 Jul;72(3):203-5. doi: 10.1016/j.maturitas.2012.04.008. Epub 2012 May 16.

  PMID: 22607813 BACKGROUND

• Huang HC, Chen YT, Chen PY, Huey-Lan Hu S, Liu F, Kuo YL, Chiu HY. Reminiscence Therapy Improves Cognitive Functions and Reduces Depressive Symptoms in Elderly People With Dementia: A Meta-Analysis of Randomized Controlled Trials. J Am Med Dir Assoc. 2015 Dec;16(12):1087-94. doi: 10.1016/j.jamda.2015.07.010. Epub 2015 Sep 1.

  PMID: 26341034 BACKGROUND

• Yates LA, Orrell M, Spector A, Orgeta V. Service users' involvement in the development of individual Cognitive Stimulation Therapy (iCST) for dementia: a qualitative study. BMC Geriatr. 2015 Feb 6;15:4. doi: 10.1186/s12877-015-0004-5.

  PMID: 25655940 BACKGROUND

MeSH Terms

Conditions

Dementia; Recurrence

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olu Olofinboba, MS

  Moai Technologies LLC

  PRINCIPAL INVESTIGATOR

• Marla Berg-Weger, PhD

  St. Louis University

  STUDY DIRECTOR

• Keith Anderson, PhD

  The University of Texas at Arlington

  STUDY DIRECTOR

Central Study Contacts

Thomas Havey, MBA, JD

CONTACT

763 515 5333; moaitechnologies@gmail.com

Olu Olofinboba, MS

CONTACT

9529944935; olu@ieee.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A social work graduate assistant from Dr. Berg-Weger's program and Dr. Anderson's program will administer the various behavioral tests that will produce the outcome measures. This will be a different individual than the graduate assistants who conduct the RT sessions with participants. Also the assistant administering the tests will be blind as to the treatment assignment of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 10, 2018
• Study Start: November 30, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: At the conclusion of the project, approximately November, 2022
• Access Criteria: other researchers in the area of Reminiscence Therapy

Locations

US (2)