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Life Story Questionnaire and Physical Therapy Participation

Primary Purpose

Dementia Alzheimers

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life story questionnaire
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia Alzheimers focused on measuring Dementia, Life story questionnaire, Physical therapy, Physiotherapy, Participation, Exercise

Eligibility Criteria

60 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Peachtree Place (Dementia care facility)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Usage of Life Story Questionnaire

No usage of Life Story Questionnaire

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 17, 2023
Last Updated
May 26, 2023
Sponsor
Texas Tech University Health Sciences Center
Collaborators
Texas Tech University
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1. Study Identification

Unique Protocol Identification Number
NCT05827276
Brief Title
Life Story Questionnaire and Physical Therapy Participation
Official Title
Effects of the Life Story Questionnaire on Physical Therapy Participation in Patients With Dementia: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center
Collaborators
Texas Tech University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Alzheimers
Keywords
Dementia, Life story questionnaire, Physical therapy, Physiotherapy, Participation, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usage of Life Story Questionnaire
Arm Type
Experimental
Arm Description
This group will receive 6 weeks of physical therapy treatment as usual with the usage of the Life story questionnaire.
Arm Title
No usage of Life Story Questionnaire
Arm Type
No Intervention
Arm Description
This group will receive 6 weeks of physical therapy treatment as usual with no usage of the Life Story Questionnaire.
Intervention Type
Other
Intervention Name(s)
Life story questionnaire
Intervention Description
Participant will receive physical therapy treatment as usual using information from Life Story Questionnaire.
Primary Outcome Measure Information:
Title
Pittsburgh Rehabilitation Participation Scale
Description
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.
Time Frame
1st week of physical therapy
Title
Pittsburgh Rehabilitation Participation Scale
Description
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.
Time Frame
3rd week of Physical Therapy
Title
Pittsburgh Rehabilitation Participation Scale
Description
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.
Time Frame
6th week of Physical Therapy
Secondary Outcome Measure Information:
Title
Quality of life in Alzheimer's disease scale- participant's version
Description
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.
Time Frame
1st week of Physical Therapy
Title
Quality of life in Alzheimer's disease scale- participant's version
Description
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.
Time Frame
3rd week of Physical Therapy
Title
Quality of life in Alzheimer's disease scale- participant's version
Description
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.
Time Frame
6th week of Physical Therapy
Title
Quality of life - Alzheimer's disease - participant's version
Description
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.
Time Frame
6 weeks following intervention of Physical Therapy
Other Pre-specified Outcome Measures:
Title
Cornell scale for depression in dementia
Description
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.
Time Frame
1st week of Physical Therapy
Title
Cornell scale for depression in dementia
Description
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.
Time Frame
3rd week of Physical Therapy
Title
Cornell scale for depression in dementia
Description
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.
Time Frame
6th week of Physical Therapy
Title
Cornell scale for depression in dementia
Description
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.
Time Frame
6 weeks following intervention of Physical Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megha S Shah, DPT
Phone
770-2414526
Email
meghashah@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Brite, OT
Phone
817-3135179
Email
allisbrite@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Brismee, ScD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Singer, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peachtree Place (Dementia care facility)
City
Weatherford
State/Province
Texas
ZIP/Postal Code
76086
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megha Shah, DPT
Phone
770-241-4526
Email
meghashah83@gmail.com
First Name & Middle Initial & Last Name & Degree
Lisa Brite, OT, BS
Phone
817-599-4181

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Links:
URL
http://www.crisisprevention.com/Blog/Use-This-Life-Story-Questionnaire-for-More-Person
Description
Life Story Questionnaire
URL
http://www.gpower.hhu.de/
Description
Statistic software
URL
http://www.jamovi.org
Description
Statistic software

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Life Story Questionnaire and Physical Therapy Participation

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