NCT05827276

Brief Summary

The goal of this clinical trial is to see the effect of life story questionnaire (LSQ) on physical therapy participation in patients with dementia. The main question\[s\] it aims to answer are:

  1. 1.What is the effect of LSQ usage on physical therapy participation in people with dementia?
  2. 2.What is the effect of LSQ usage on depression in people with dementia?
  3. 3.What is the effect of LSQ usage on the quality of life in people with dementia? The researcher will compare these effects between the intervention group (usage of the Life Story Questionnaire) and the control group (no usage of the Life story questionnaire).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 26, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

May 31, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

March 17, 2023

Last Update Submit

May 26, 2023

Conditions

Keywords

DementiaLife story questionnairePhysical therapyPhysiotherapyParticipationExercise

Outcome Measures

Primary Outcomes (3)

  • Pittsburgh Rehabilitation Participation Scale

    To measure participation in physical therapy. Participation is graded as none (1), Poor (2), Fair (3), Good (4), Very good (5), and Excellent (6). Higher score indicates greater participation in physical therapy sessions.

    1st week of physical therapy

  • Pittsburgh Rehabilitation Participation Scale

    To measure participation in physical therapy. Participation is graded as none (1), Poor (2), Fair (3), Good (4), Very good (5), and Excellent (6). Higher score indicates greater participation in physical therapy sessions.

    3rd week of Physical Therapy

  • Pittsburgh Rehabilitation Participation Scale

    To measure participation in physical therapy. Participation is graded as none (1), Poor (2), Fair (3), Good (4), Very good (5), and Excellent (6). Higher score indicates greater participation in physical therapy sessions.

    6th week of Physical Therapy

Secondary Outcomes (4)

  • Quality of life in Alzheimer's disease scale- participant's version

    1st week of Physical Therapy

  • Quality of life in Alzheimer's disease scale- participant's version

    3rd week of Physical Therapy

  • Quality of life in Alzheimer's disease scale- participant's version

    6th week of Physical Therapy

  • Quality of life - Alzheimer's disease - participant's version

    6 weeks following intervention of Physical Therapy

Other Outcomes (4)

  • Cornell scale for depression in dementia

    1st week of Physical Therapy

  • Cornell scale for depression in dementia

    3rd week of Physical Therapy

  • Cornell scale for depression in dementia

    6th week of Physical Therapy

  • +1 more other outcomes

Study Arms (2)

Usage of Life Story Questionnaire

EXPERIMENTAL

This group will receive 6 weeks of physical therapy treatment as usual with the usage of the Life story questionnaire.

Other: Life story questionnaire

No usage of Life Story Questionnaire

NO INTERVENTION

This group will receive 6 weeks of physical therapy treatment as usual with no usage of the Life Story Questionnaire.

Interventions

Participant will receive physical therapy treatment as usual using information from Life Story Questionnaire.

Usage of Life Story Questionnaire

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients residing at dementia facility in Texas;
  • Age 60-89 years;
  • Diagnosis of dementia disease, in mild to the moderate stage using the Mini-Mental State Examination (score between 10 -24) and
  • Attendance to physical therapy for 6 weeks.

You may not qualify if:

  • Unable to speak English;
  • Blindness;
  • Deafness;
  • Mini-Mental State Examination score \>24 and
  • history of major psychiatric disorders such as schizophrenia and bipolar disorder requiring hospital admission within the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peachtree Place (Dementia care facility)

Weatherford, Texas, 76086, United States

RECRUITING

Related Publications (28)

  • 2018 Alzheimer's Disease Facts and figures" (2018) Alzheimer's & Dementia, 14(3), pp. 367-429. Available at: https://doi.org/10.1016/j.jalz.2018.02.001.

    BACKGROUND
  • Arvanitakis Z, Bennett DA. What Is Dementia? JAMA. 2019 Nov 5;322(17):1728. doi: 10.1001/jama.2019.11653. No abstract available.

    PMID: 31688886BACKGROUND
  • Machiels M, Metzelthin SF, Hamers JP, Zwakhalen SM. Interventions to improve communication between people with dementia and nursing staff during daily nursing care: A systematic review. Int J Nurs Stud. 2017 Jan;66:37-46. doi: 10.1016/j.ijnurstu.2016.11.017. Epub 2016 Nov 30.

    PMID: 27951433BACKGROUND
  • Alsawy S, Mansell W, McEvoy P, Tai S. What is good communication for people living with dementia? A mixed-methods systematic review. Int Psychogeriatr. 2017 Nov;29(11):1785-1800. doi: 10.1017/S1041610217001429. Epub 2017 Jul 31.

    PMID: 28756788BACKGROUND
  • Sari YM, Burton E, Lee DA, Hill KD. Current physiotherapy practice on delivering treatments for older people with dementia in Indonesia: A cross-sectional study. Physiother Res Int. 2022 Jan;27(1):e1931. doi: 10.1002/pri.1931. Epub 2021 Nov 2.

    PMID: 34727408BACKGROUND
  • Hoel V, Feunou CM, Wolf-Ostermann K. Technology-driven solutions to prompt conversation, aid communication and support interaction for people with dementia and their caregivers: a systematic literature review. BMC Geriatr. 2021 Mar 4;21(1):157. doi: 10.1186/s12877-021-02105-0.

    PMID: 33663401BACKGROUND
  • American Geriatrics Society Expert Panel on Person-Centered Care. Person-Centered Care: A Definition and Essential Elements. J Am Geriatr Soc. 2016 Jan;64(1):15-8. doi: 10.1111/jgs.13866. Epub 2015 Dec 2.

    PMID: 26626262BACKGROUND
  • BUTLER RN. The life review: an interpretation of reminiscence in the aged. Psychiatry. 1963 Feb;26:65-76. doi: 10.1080/00332747.1963.11023339. No abstract available.

    PMID: 14017386BACKGROUND
  • McKeown J, Clarke A, Repper J. Life story work in health and social care: systematic literature review. J Adv Nurs. 2006 Jul;55(2):237-47. doi: 10.1111/j.1365-2648.2006.03897.x.

    PMID: 16866815BACKGROUND
  • Woods B, O'Philbin L, Farrell EM, Spector AE, Orrell M. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2018 Mar 1;3(3):CD001120. doi: 10.1002/14651858.CD001120.pub3.

    PMID: 29493789BACKGROUND
  • Zarit SH, Chiusano C, Harrison AS, Sewell L, Krause C, Liu Y. Rehabilitation of persons with dementia: using technology to improve participation. Aging Ment Health. 2021 Mar;25(3):543-550. doi: 10.1080/13607863.2020.1711864. Epub 2020 Jan 16.

    PMID: 31941356BACKGROUND
  • Lazar A, Demiris G, Thompson HJ. Evaluation of a multifunctional technology system in a memory care unit: Opportunities for innovation in dementia care. Inform Health Soc Care. 2016 Dec;41(4):373-86. doi: 10.3109/17538157.2015.1064428. Epub 2016 Jan 28.

    PMID: 26819070BACKGROUND
  • Cooney A, O'Shea E. The impact of life story work on person-centred care for people with dementia living in long-stay care settings in Ireland. Dementia (London). 2019 Oct-Nov;18(7-8):2731-2746. doi: 10.1177/1471301218756123. Epub 2018 Feb 7. No abstract available.

    PMID: 29411663BACKGROUND
  • Rashid MH, Zahid MF, Zain S, Kabir A, Hassan SU. The Neuroprotective Effects of Exercise on Cognitive Decline: A Preventive Approach to Alzheimer Disease. Cureus. 2020 Feb 11;12(2):e6958. doi: 10.7759/cureus.6958.

    PMID: 32190507BACKGROUND
  • Crocker T, Forster A, Young J, Brown L, Ozer S, Smith J, Green J, Hardy J, Burns E, Glidewell E, Greenwood DC. Physical rehabilitation for older people in long-term care. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD004294. doi: 10.1002/14651858.CD004294.pub3.

    PMID: 23450551BACKGROUND
  • Hall AJ, Burrows L, Lang IA, Endacott R, Goodwin VA. Are physiotherapists employing person-centred care for people with dementia? An exploratory qualitative study examining the experiences of people with dementia and their carers. BMC Geriatr. 2018 Mar 2;18(1):63. doi: 10.1186/s12877-018-0756-9.

    PMID: 29499661BACKGROUND
  • Kales HC, Gitlin LN, Lyketsos CG; Detroit Expert Panel on Assessment and Management of Neuropsychiatric Symptoms of Dementia. Management of neuropsychiatric symptoms of dementia in clinical settings: recommendations from a multidisciplinary expert panel. J Am Geriatr Soc. 2014 Apr;62(4):762-9. doi: 10.1111/jgs.12730. Epub 2014 Mar 17.

    PMID: 24635665BACKGROUND
  • Kitching D. Depression in dementia. Aust Prescr. 2015 Dec;38(6):209-2011. doi: 10.18773/austprescr.2015.071. Epub 2015 Dec 1.

    PMID: 26843714BACKGROUND
  • Burks HB, des Bordes JKA, Chadha R, Holmes HM, Rianon NJ. Quality of Life Assessment in Older Adults with Dementia: A Systematic Review. Dement Geriatr Cogn Disord. 2021;50(2):103-110. doi: 10.1159/000515317. Epub 2021 Jun 24.

    PMID: 34167127BACKGROUND
  • Creavin ST, Wisniewski S, Noel-Storr AH, Trevelyan CM, Hampton T, Rayment D, Thom VM, Nash KJ, Elhamoui H, Milligan R, Patel AS, Tsivos DV, Wing T, Phillips E, Kellman SM, Shackleton HL, Singleton GF, Neale BE, Watton ME, Cullum S. Mini-Mental State Examination (MMSE) for the detection of dementia in clinically unevaluated people aged 65 and over in community and primary care populations. Cochrane Database Syst Rev. 2016 Jan 13;2016(1):CD011145. doi: 10.1002/14651858.CD011145.pub2.

    PMID: 26760674BACKGROUND
  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND
  • Lenze EJ, Munin MC, Quear T, Dew MA, Rogers JC, Begley AE, Reynolds CF 3rd. The Pittsburgh Rehabilitation Participation Scale: reliability and validity of a clinician-rated measure of participation in acute rehabilitation. Arch Phys Med Rehabil. 2004 Mar;85(3):380-4. doi: 10.1016/j.apmr.2003.06.001.

    PMID: 15031821BACKGROUND
  • Weyer G, Erzigkeit H, Kanowski S, Ihl R, Hadler D. Alzheimer's Disease Assessment Scale: reliability and validity in a multicenter clinical trial. Int Psychogeriatr. 1997 Jun;9(2):123-38. doi: 10.1017/s1041610297004298.

    PMID: 9309486BACKGROUND
  • Korner A, Lauritzen L, Abelskov K, Gulmann N, Marie Brodersen A, Wedervang-Jensen T, Marie Kjeldgaard K. The Geriatric Depression Scale and the Cornell Scale for Depression in Dementia. A validity study. Nord J Psychiatry. 2006;60(5):360-4. doi: 10.1080/08039480600937066.

    PMID: 17050293BACKGROUND
  • Gbiri CAO, Amusa BF. Progressive task-oriented circuit training for cognition, physical functioning and societal participation in individuals with dementia. Physiother Res Int. 2020 Oct;25(4):e1866. doi: 10.1002/pri.1866. Epub 2020 Aug 10.

    PMID: 32776698BACKGROUND
  • AsanoT, Wang C-W, Tsugaruva M, Ishikawa T. Effectiveness of high- frequency individual reminiscence interventions using life story books on person with dementia. British Journal of Occupational therapy. 2021:84(5):317-326.

    BACKGROUND
  • Duong S, Patel T, Chang F. Dementia: What pharmacists need to know. Can Pharm J (Ott). 2017 Feb 7;150(2):118-129. doi: 10.1177/1715163517690745. eCollection 2017 Mar-Apr. No abstract available.

  • Elfrink TR, Zuidema SU, Kunz M, Westerhof GJ. Life story books for people with dementia: a systematic review. Int Psychogeriatr. 2018 Dec;30(12):1797-1811. doi: 10.1017/S1041610218000376. Epub 2018 Jul 18.

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDementiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Jean-Michel Brismee, ScD

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR
  • Jonathan Singer, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megha S Shah, DPT

CONTACT

Lisa Brite, OT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blind to the usage of the life story questionnaire for study participants. Additionally, the participants will not be told the group they were allocated to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective Randomized Control Trial. Patients will be randomly allocated in two groups: (1) Control group, which will receive standard physical therapy care without LSQ use; and (2) Experimental group, where physical therapists will use the LSQ.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal co-investigator

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 25, 2023

Study Start

April 26, 2023

Primary Completion

December 30, 2023

Study Completion

March 30, 2024

Last Updated

May 31, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations