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| Name | Class |
|---|---|
| Texas Tech University | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life story questionnaire | Other | Participant will receive physical therapy treatment as usual using information from Life Story Questionnaire. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1st week of Physical Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Cornell scale for depression in dementia | It is a a screening tool and assesses depression symptoms in dementia participants. Score ranges from a - unable to evaluate, 0- absent, 1- mild, 2- severe. Minimum score is 0 and maximum score is 38. Higher scores indicate greater depression. | 1st week of Physical Therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megha S Shah, DPT | Contact | 770-2414526 | meghashah@gmail.com | |
| Lisa Brite, OT | Contact | 817-3135179 | allisbrite@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel Brismee, ScD | Texas Tech University Health Sciences Center | Principal Investigator |
| Jonathan Singer, PhD | Texas Tech University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peachtree Place (Dementia care facility) | Recruiting | Weatherford | Texas | 76086 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 31688886 | Background | Arvanitakis Z, Bennett DA. What Is Dementia? JAMA. 2019 Nov 5;322(17):1728. doi: 10.1001/jama.2019.11653. No abstract available. | |
| 27951433 |
| Label | URL |
|---|---|
| Life Story Questionnaire | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 5, 2024 | |
| Reset | Sep 17, 2024 | |
| Release | Sep 23, 2024 | |
| Reset | Nov 15, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 24, 2023 | Apr 24, 2023 | Prot_SAP_ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 5, 2024 | Sep 17, 2024 | |||
| Sep 23, 2024 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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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.
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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.
| 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. |
| 3rd week of Physical Therapy |
| 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. | 6th week of Physical Therapy |
| 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. | 6 weeks following intervention of Physical Therapy |
| Cornell scale for depression in dementia |
It is a a screening tool and assesses depression symptoms in dementia participants. Score ranges from a - unable to evaluate, 0- absent, 1- mild, 2- severe. Minimum score is 0 and maximum score is 38. Higher scores indicate greater depression. |
| 3rd week of Physical Therapy |
| Cornell scale for depression in dementia | It is a a screening tool and assesses depression symptoms in dementia participants. Score ranges from a - unable to evaluate, 0- absent, 1- mild, 2- severe. Minimum score is 0 and maximum score is 38. Higher scores indicate greater depression. | 6th week of Physical Therapy |
| Cornell scale for depression in dementia | It is a a screening tool and assesses depression symptoms in dementia participants. Score ranges from a - unable to evaluate, 0- absent, 1- mild, 2- severe. Minimum score is 0 and maximum score is 38. Higher scores indicate greater depression. | 6 weeks following intervention of Physical Therapy |
| Background |
| 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. |
| 28756788 | Background | 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. |
| 34727408 | Background | 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. |
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| 29411663 | Background | 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. |
| 32190507 | Background | 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. |
| 23450551 | Background | 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. |
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| 24635665 | Background | 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. |
| 26843714 | Background | Kitching D. Depression in dementia. Aust Prescr. 2015 Dec;38(6):209-2011. doi: 10.18773/austprescr.2015.071. Epub 2015 Dec 1. |
| 34167127 | Background | 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. |
| 26760674 | Background | 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. |
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| Statistic software | View source |
| Statistic software | View source |
| Nov 15, 2024 |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |