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Dementia AlzheimersNCT05827276

Life Story Questionnaire and Physical Therapy Participation

A study testing Life story questionnaire in people with Dementia Alzheimers, run by Texas Tech University Health Sciences Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. What is the effect of LSQ usage on physical therapy participation in people with dementia? 2. Read more about this study

Who is it for?
Ages 60 to 89 years
Conditions the study is for
Dementia Alzheimers
What is being tested?
Life story questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
26 Apr 2023to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Megha S Shah, DPT contact

770-2414526

meghashah@gmail.com

Lisa Brite, OT contact

817-3135179

allisbrite@gmail.com

United States1 site, 1 recruiting

  • Peachtree Place (Dementia care facility)

    Weatherford, Texas, 76086

    Megha Shah, DPT, 770-241-4526, meghashah83@gmail.com

    Lisa Brite, OT, BS, 817-599-4181

    Recruiting

Other trials in United States

About this study

Official title: Effects of the Life Story Questionnaire on Physical Therapy Participation in Patients With Dementia: A Randomized Control Trial

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. What is the effect of LSQ usage on physical therapy participation in people with dementia?
  2. What is the effect of LSQ usage on depression in people with dementia?
  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).
Read more

All Participants will receive Physical therapy treatment as usual. The life Story Questionnaire will be used in the intervention group during physical therapy treatment.

Life Story Questionnaire: It is developed by the Crisis Prevention Institute, which is a type of life story book for people with dementia. The LSQ allows caregivers to start conversations about topics that are important to each patient, can help establish rapport between the caregiver and patient.

Read the detailed description

Background: Dementia is characterized by a progressive decline in cognitive function. Dementia disease prevalence is substantially increased among people aged 65 years or older, with a progressive decline in memory, thinking, language and learning capacity. Although physical exercise benefits dementia patients, participation in activities is exceedingly difficult due to communication and cognitive impairments. Several studies demonstrated that life story books usage improved quality of life, depression symptoms, moods and participation in activity in people with dementia. However, these studies did not evaluate the effect of Life Story Questionnaire (LSQ) - a type of life story book - on physical therapy participation, depression symptoms, quality of life.

Objectives: To evaluate the impact of LSQ on (1) participation in physical therapy using Pittsburgh Rehabilitation Participation Scale; (2) quality of life using Quality of Life - Alzheimer's Disease Scale (participant's version); and (3) depression symptoms using Cornell Scale for Depression in Dementia (CSDD).

Methods: A consecutive sample of convenience of up to 60 patients with mild to moderate cognitive impairment with 44 (22 per group) completing the study will be recruited from a nursing home facility. 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. Each patient's family member will receive a LSQ to complete prior to the start of the intervention. Patients' participation, quality of life and depression symptoms will be measured on day 1 and again after 3 weeks (mid-term), and 6 weeks of intervention. Quality of life and depression symptoms will also be measured 6 weeks following intervention. A licensed occupational therapist blinded to the participants' group allocation will measure all three dependent variables

Statistical Analysis: Descriptive statistics including means, standard deviations, frequency counts, median, mode, variance and frequency counts will be used to assess sample demographics. The Rank Sum test will be used to assess differences in Pittsburgh Rehabilitation Participation Scale between the intervention and control group. Spearman Rank correlations will be used to determine the strength of the correlation between Mini-Mental state examination, Pittsburgh Rehabilitation Participation Scale and Quality of Life Alzheimer Disease.

Being tested
Life story questionnaire
Keywords
Dementia, Life story questionnaire, Physical therapy, Physiotherapy, Participation, Exercise
Medical subject headings
Alzheimer Disease, Dementia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Life story questionnaireOther

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

Study groups in NCT05827276
Study groupRoleWhat they receive
Usage of Life Story QuestionnaireExperimentalThis group will receive 6 weeks of physical therapy treatment as usual with the usage of the Life story questionnaire.
Receives: Other: Life story questionnaire
No usage of Life Story QuestionnaireNo interventionThis group will receive 6 weeks of physical therapy treatment as usual with no usage of the Life Story Questionnaire.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1st week of physical therapy

  2. 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.

    Measured: 3rd week of Physical Therapy

  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.

    Measured: 6th week of Physical Therapy

Secondary outcomes (4)

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

    The quality of life in Alzheimer's disease scale rates 13 types of life domains and uses a scale of poor (1), fair (2), good (3), and excellent (4). Minimum score is 13 and maximum score is 52. Higher scores indicate better quality of life.

    Measured: 1st week of Physical Therapy

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

    The quality of life in Alzheimer's disease scale rates 13 types of life domains and uses a scale of poor (1), fair (2), good (3), and excellent (4). Minimum score is 13 and maximum score is 52. Higher scores indicate better quality of life.

    Measured: 3rd week of Physical Therapy

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

    The quality of life in Alzheimer's disease scale rates 13 types of life domains and uses a scale of poor (1), fair (2), good (3), and excellent (4). Minimum score is 13 and maximum score is 52. Higher scores indicate better quality of life.

    Measured: 6th week of Physical Therapy

  4. Quality of life - Alzheimer's disease - participant's version

    The quality of life in Alzheimer's disease scale rates 13 types of life domains and uses a scale of poor (1), fair (2), good (3), and excellent (4). Minimum score is 13 and maximum score is 52. Higher scores indicate better quality of life.

    Measured: 6 weeks following intervention of Physical Therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start26 Apr 2023
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827276
Sponsor's protocol ID
IRB2023-103
Status last verified
Apr 2023
First submitted
17 Mar 2023
Last updated
31 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

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

    PubMed 31688886

  • 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.

    PubMed 27951433

  • 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.

    PubMed 28756788

  • 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.

    PubMed 34727408

  • 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.

    PubMed 33663401

  • 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.

    PubMed 26626262

  • 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.

    PubMed 14017386

  • 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.

    PubMed 16866815

  • 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.

    PubMed 29493789

  • 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.

    PubMed 31941356

  • 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.

    PubMed 26819070

  • 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.

    PubMed 29411663

  • 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.

    PubMed 32190507

  • 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.

    PubMed 23450551

Questions about this trial

What is this clinical trial studying?

A study testing Life story questionnaire in people with Dementia Alzheimers, run by Texas Tech University Health Sciences Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Megha S Shah, DPT (770-2414526, meghashah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Rehabilitation Participation Scale (time frame: 1st week of physical therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827276, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

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