Creating Physical Objects With 3D Printers to Stimulate Reminiscing for Memory Loss [2 R44 AG049548-02A1]
NCT ID: NCT03625973
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2021-11-30
2022-11-30
Brief Summary
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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.
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Detailed Description
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The objective of the field evaluation is to determine the effectiveness of reminiscence therapy (RT) using replicas of personal objects produced by 3D printing. To address this objective, randomized control field trials will be conducted in which the effects of high and low doses of RT using 3D-printed objects will be compared to the effects of using only traditional verbally-presented stimuli during RT. Effects will be measured on autobiographical memory, psycho-social status, and quality of life.
Participants:
The Co- Investigators, Dr. Berg-Weger and Dr. Anderson, in cooperation with the participating care organizations, will identify a total of 156 persons with memory loss of varying gender, race, and ethnicity to participate in the field trial.
Study Design and Implementation:
Two hypotheses will be tested. Hypothesis 1. An RT program dose consisting of 16 weeks of RT sessions using personalized physical objects produced by 3D printing will result in more and richer autobiographical reminiscence than a 16 week RT program dose consisting of 8 weeks of RT sessions using personalized 3D objects followed by 8 weeks of RT using verbal stimuli. Further, it is hypothesized that a full 16 weeks of RT using 3D objects will have a more significant positive effect on overall cognitive functioning, communication, and quality of life than 8 weeks of RT using 3D objects plus 8 weeks of RT using verbal memory stimuli.
Hypothesis 2. Both programs of RT using personalized physical 3D-printed objects will result in significantly greater and richer autobiographical reminiscence than a program consisting of 16 weeks of more traditional RT using verbal memory stimuli, and also have a positive effect on overall cognitive functioning, communication, and quality of life.
Study Design:
A between groups design will be used to examine these hypotheses, with participants assigned randomly to one of three groups:
1. a High Dose group receiving RT using personalized 3D objects for 16 weeks,
2. a Low Dose group receiving RT using personalized 3D objects for 8 weeks followed by 8 weeks of RT using traditional verbal stimuli, or
3. a control group receiving more traditional RT using verbal stimuli related to personal objects of interest.
The proposed high and low RT dosages are based on the higher and lower range dosages reported in two recent meta-analyses of RT. Personalized 3D objects will be identified for 3D-RT group participants by the therapist using a mobile application developed specifically for this project. Verbal stimuli for RT for the traditional RT group will be developed using exactly the same life history questions used in the mobile application. Questions will be selected from the list and discussed, one by one, until the discussion leads to a topic being identified by the Person With Memory Loss (PWML). An effort will be made to ensure that this process of identifying verbal stimuli for the Verbal RT group participants involves therapist contact time equivalent to that expended by the therapist in identifying personalized 3D objects for 3D-RT group participants.
Thirty-minute therapy sessions will be conducted 1 time each week for 16 weeks. Every two weeks, a new 3D object will be identified by the caregiver/therapist working with the PWML, printed by Moai Technologies, and introduced to the therapy. Thus, each object or topic will serve as the RT stimulus for two sessions. In the unlikely event that the 3D object does not stimulate a full 30 minutes of discussion, the therapist will be prepared with more general reminiscence topics to introduce so that a full 30-minute session can be completed and contact time across sessions held constant. Participating RT therapists will be trained on how to make the transition. For those in the Verbal-RT group, a new verbally-presented topic of autobiographical interest to the PWML will be identified and introduced every two weeks. As with the 3D object groups, if the identified topic does not stimulate a full 30 minutes of discussion, the therapist will be prepared with more general reminiscence topics to introduce so that a full 30-minute session can be completed.
This approach to delivering RT by means of regular, structured sessions with a trained caregiver draws on the successful paradigm developed in the United Kingdom for Individual Cognitive Stimulation Therapy (CST). Notably, all project collaborators in the St. Louis area are part of the university's CST network. Thus, they are already familiar with this paradigm and can easily adapt it to the program of RT sessions proposed here. This project's field collaborator in the Missoula area, The Goodman Group, is eager to be trained and to set up this RT paradigm in their Missoula and Hamilton, Montana facilities.
Data Collection:
PWMLs, assisted by caregivers as necessary, will complete the measures described below three times: 1) prior to the beginning of RT trials, 2) after the 8th week of RT, 3) at the end of the 16-week therapy period. It is estimated that completing these tests will require a total of 70 minutes of time for the PWML and 15-30 minutes for the caregiver.
Summary of Measures:
1. Measure: Cognitive stimulation/reminiscence. Instrument: Autobiographical Memory Interview (AMI), Kopelman, Wilson, and Baddeley, 1989
2. Measure: Dementia severity Instruments: Saint Louis University Mental Status (SLUMS), Tariq, Tumosa, Chibnall, Perry, 2006 Revised Memory and Behavior Problems Checklist (R-MBPC), Teri, Truax, Logsdon, Uomoto, Zarit, Vitaliano, 1992
3. Measure: Social engagement Instrument: Pleasant Events Schedule-AD (PES-AD), Lodsdon, Teri, 1997
4. Measure: Mood Instrument: Geriatric Depression Scale (GDS), van Marwijk, Wallace, de Bock, 1995
5. Measure: Quality of life Instrument: Dementia Quality of Life (DQoL), Brod, Stewart, Sands, Walton, 1999
Interviews. At the end of the 16-week period, interviews will be conducted with all participating RT therapists and with a sample of 15-20 PWMLs who reported the greatest increase in quality of life during the 16 week therapy period. A stratified sampling approach will be used to select the PWMLs for interviews and will consider dementia severity and racial or ethnic background. The experiences of RT therapists and PWMLs with using the 3D printed objects in RT sessions and the online and mobile tools, will be assessed with both structured and open-ended questioning.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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16 Weeks of 3D-RT
Participants will receive 16 weeks of Reminiscence Therapy using 3D printed objects as stimuli.
3D-RT
Objects printed using 3D printing media will be used as stimuli in Reminiscence Therapy
8 Weeks of 3D-RT
Participants will receive 8weeks of Reminiscence Therapy using 3D printed objects as stimuli and 8 weeks of RT using verbal stimuli.
3D-RT
Objects printed using 3D printing media will be used as stimuli in Reminiscence Therapy
16 Weeks of RT using Verbal Stimuli
Participants will receive 16 weeks of RT using verbal stimuli to reminiscence.
RT-Verbal
Verbal cues will be used as stimuli in Reminiscence Therapy
Interventions
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3D-RT
Objects printed using 3D printing media will be used as stimuli in Reminiscence Therapy
RT-Verbal
Verbal cues will be used as stimuli in Reminiscence Therapy
Eligibility Criteria
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Inclusion Criteria
2. Physician diagnosis of early-stage Alzheimer's disease or mild cognitive impairment
3. Score of 10 or above on the brief St. Louis University Mental Status examination (SLUMS).
Exclusion Criteria
ALL
No
Sponsors
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St. Louis University
OTHER
The University of Texas at Arlington
OTHER
Moai Technologies LLC
OTHER
Responsible Party
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Principal Investigators
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Olu Olofinboba, MS
Role: PRINCIPAL_INVESTIGATOR
Moai Technologies LLC
Marla Berg-Weger, PhD
Role: STUDY_DIRECTOR
St. Louis University
Keith Anderson, PhD
Role: STUDY_DIRECTOR
The University of Texas at Arlington
Locations
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Saint Louis University
St Louis, Missouri, United States
University of Texas Arlington
Arlington, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Marla Berg-Weger, Ph.D.
Role: primary
Keith Anderson, Ph.D.
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MoaiTech
Identifier Type: -
Identifier Source: org_study_id
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