Clinical trial NCT03625973: Creating Physical Objects With 3D Printers to Stimulate Reminiscing for Memory Loss [2 R44 AG049548-02A1]
Official title: Creating Physical Objects With 3D Printers to Stimulate Reminiscing for Memory Loss [2 R44 AG049548-02A1]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: Dementia
Memory, Episodic
Printing, Three-Dimensional
Lead sponsor: Moai Technologies LLC
Sponsor class: OTHER
Collaborators: name: St. Louis University
name: The University of Texas at Arlington
First posted: 2018-08-10
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Objective:

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.

Eligibility criteria: Inclusion Criteria:

1. English speaking
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:

-

Primary outcomes:
measure: Change in Cognitive stimulation/reminiscence
timeFrame: 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:
measure: Change in Dementia severity-SLUMS
timeFrame: 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.
measure: Change in Dementia severity-Frequency of Behavioral Problems
timeFrame: 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.
measure: Change in Dementia severity-dependence on assistance
timeFrame: 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.
measure: Change in Social engagement
timeFrame: 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.
measure: Change in Mood
timeFrame: 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.
measure: Change in Quality of Life (self-esteem, positive affect, negative affect, and sense of aesthetics)
timeFrame: 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:
measure: Functionality and usability of 3D printing mobile tools and paradigm for RT
timeFrame: Interviews will be conducted at 16 weeks
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Arlington
country: United States
facility: University of Texas Arlington
state: Texas
Study officials:
affiliation: Moai Technologies LLC
name: Olu Olofinboba, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University
name: Marla Berg-Weger, PhD
role: STUDY_DIRECTOR
affiliation: The University of Texas at Arlington
name: Keith Anderson, PhD
role: STUDY_DIRECTOR
References:
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