Clinical trial NCT05827276: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia Alzheimers
Keywords: Dementia
Life story questionnaire
Physical therapy
Physiotherapy
Participation
Exercise
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: Texas Tech University
First posted: 2023-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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. 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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Pittsburgh Rehabilitation Participation Scale
timeFrame: 1st week of physical therapy
measure: Pittsburgh Rehabilitation Participation Scale
timeFrame: 3rd week of Physical Therapy
measure: Pittsburgh Rehabilitation Participation Scale
timeFrame: 6th week of Physical Therapy
Secondary outcomes:
measure: Quality of life in Alzheimer's disease scale- participant's version
timeFrame: 1st week of Physical Therapy
measure: Quality of life in Alzheimer's disease scale- participant's version
timeFrame: 3rd week of Physical Therapy
measure: Quality of life in Alzheimer's disease scale- participant's version
timeFrame: 6th week of Physical Therapy
measure: Quality of life - Alzheimer's disease - participant's version
timeFrame: 6 weeks following intervention of Physical Therapy
Other outcomes:
measure: Cornell scale for depression in dementia
timeFrame: 1st week of Physical Therapy
measure: Cornell scale for depression in dementia
timeFrame: 3rd week of Physical Therapy
measure: Cornell scale for depression in dementia
timeFrame: 6th week of Physical Therapy
measure: Cornell scale for depression in dementia
timeFrame: 6 weeks following intervention of Physical Therapy
Locations:
city: Weatherford
country: United States
facility: Peachtree Place (Dementia care facility)
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Jean-Michel Brismee, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University
name: Jonathan Singer, PhD
role: PRINCIPAL_INVESTIGATOR
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