Trial Outcomes & Findings for Life Story Book With Mentally Alert Residents of Nursing Homes (NCT NCT03851016)
NCT ID: NCT03851016
Last Updated: 2020-06-02
Results Overview
The Geriatric Depression Scale (Residential) (GDS-12R) is a validated, self-reported instrument assessing depression over the past 7 days. It is a "yes/no" format. Possible scores range from 0 (no depressive symptoms) to 10 (depression). A score of 0 to 4 is normal; scores ≥ 4 are significant for depressive symptoms; scores ≥ 08 is almost always indicative of depression. A score ≥ 5 points should warrant a follow-up comprehensive assessment.
COMPLETED
NA
24 participants
Baseline and 3 weeks
2020-06-02
Participant Flow
27 residents were screened for eligibility between April 08, 2019 and April 12, 2019 from two comparable nursing homes in the Houston Texas Metropolitan area.
24 of the 27 participants, 12 from each home met inclusion criteria. The two nursing homes were allocated by the PI to either Life Story Book Intervention first or Usual Care first. All participants in the same nursing home received the same intervention at the same time.
Participant milestones
| Measure |
Life Story Book Intervention First, Then Usual Care
Participants first received the Life Story Book Intervention for one hour each week for 3 weeks. After a washout period of 1 week and measures collected (Time 2), they then received the Usual Care intervention for 3 weeks. Posttests (Time 3) were conducted the week after the Usual Care intervention.
|
Usual Care First, Then Life Story Book Intervention
Participants first received the Usual Care Intervention for 3 weeks. After a washout period of 1 week and measures collected (Time 2), they then received the Life Story Book Intervention for one hour a week for 3 weeks. Posttests (Time 3) were conducted the week after the Life Story Book Intervention.
|
|---|---|---|
|
First Intervention (3 Weeks)
STARTED
|
12
|
12
|
|
First Intervention (3 Weeks)
COMPLETED
|
11
|
10
|
|
First Intervention (3 Weeks)
NOT COMPLETED
|
1
|
2
|
|
Washout (1 Week)
STARTED
|
11
|
10
|
|
Washout (1 Week)
COMPLETED
|
11
|
10
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Weeks)
STARTED
|
11
|
10
|
|
Second Intervention (3 Weeks)
COMPLETED
|
11
|
10
|
|
Second Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Life Story Book Intervention First, Then Usual Care
Participants first received the Life Story Book Intervention for one hour each week for 3 weeks. After a washout period of 1 week and measures collected (Time 2), they then received the Usual Care intervention for 3 weeks. Posttests (Time 3) were conducted the week after the Usual Care intervention.
|
Usual Care First, Then Life Story Book Intervention
Participants first received the Usual Care Intervention for 3 weeks. After a washout period of 1 week and measures collected (Time 2), they then received the Life Story Book Intervention for one hour a week for 3 weeks. Posttests (Time 3) were conducted the week after the Life Story Book Intervention.
|
|---|---|---|
|
First Intervention (3 Weeks)
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Life Story Book With Mentally Alert Residents of Nursing Homes
Baseline characteristics by cohort
| Measure |
Life Story Book Intervention First, Then Usual Care
n=11 Participants
Participants first received the Life Story Book Intervention for one hour a week for three weeks. After a washout period of 1 week, they then received three weeks of usual care.
|
Usual Care First, Then Life Story Book Intervention
n=10 Participants
Participants received three weeks of usual care first. After a washout period of 1 week, they then received three weeks of the Life Story Book Intervention
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.1 years
STANDARD_DEVIATION 11 • n=99 Participants
|
72.1 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
74.6 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Education, Categorical
Grades 9-11
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Education, Categorical
High School or GED
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Education, Categorical
Some College/Tech
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Education, Categorical
College Graduate, plus
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Marital Status, Categorical
Widow (R)
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Marital Status, Categorical
Divorced
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Marital Status, Categorical
Single
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Marital Status, Categorical
Married
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Length of Time at Residence
Less than 1 Year
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Length of Time at Residence
One-two years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Length of Time at Residence
Three or more years
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Katz Index of Independence in Activities of Daily Living (ADL) Continuous
|
1.27 units on a scale
STANDARD_DEVIATION .65 • n=99 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 2.3 • n=107 Participants
|
2.135 units on a scale
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Religion
Protestant
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Religion
Catholic/Other
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 weeksPopulation: All participants who received each intervention and completed all study visits were included in the efficacy analysis.
The Geriatric Depression Scale (Residential) (GDS-12R) is a validated, self-reported instrument assessing depression over the past 7 days. It is a "yes/no" format. Possible scores range from 0 (no depressive symptoms) to 10 (depression). A score of 0 to 4 is normal; scores ≥ 4 are significant for depressive symptoms; scores ≥ 08 is almost always indicative of depression. A score ≥ 5 points should warrant a follow-up comprehensive assessment.
Outcome measures
| Measure |
Life Story Book Intervention
n=21 Participants
Participants who received the Life Story Book intervention in either the first three weeks or the last three weeks of the study.
|
Usual Care
n=21 Participants
Participants who received Usual Care in either the first or last 3 weeks of the study.
|
|---|---|---|
|
Change From Baseline in Mean Scores for Geriatric Depression Scale at 3 Weeks
|
1.00 score on a scale
Standard Deviation 2.07
|
-.29 score on a scale
Standard Deviation 1.68
|
PRIMARY outcome
Timeframe: Baseline and 3 weeksPopulation: All participants who received each intervention and completed all study visits were included in the efficacy analysis.
Meaning in Life was measured using the Meaning in Life Questionnaire (MLQ), created by Steger et al. The MLQ has two sub-scales which assess the presence of meaning (POM) (how much a person feels their life has meaning) and the search for meaning (how much a person strives to find meaning and understanding in their life). The two sub-scale measures, which consist of 10 items on a 7-point Likert scale, range from 1-absolutely true to 7-absolutely untrue: five items for presence of meaning (POM) and five items for search for meaning (SFM). A POM score \> 24 indicates the person feels their life has meaning and purpose.
Outcome measures
| Measure |
Life Story Book Intervention
n=21 Participants
Participants who received the Life Story Book intervention in either the first three weeks or the last three weeks of the study.
|
Usual Care
n=21 Participants
Participants who received Usual Care in either the first or last 3 weeks of the study.
|
|---|---|---|
|
Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Presence of Meaning (POM) at 3 Weeks.
|
.952 score on a scale
Standard Deviation 6.18
|
-13.10 score on a scale
Standard Deviation 13.78
|
PRIMARY outcome
Timeframe: Baseline and 3 weeksPopulation: All participants who received each intervention and completed all study visits were included in the efficacy analysis.
Meaning in Life was measured using the Meaning in Life Questionnaire (MLQ), created by Steger et al.The MLQ has two sub-scales which assess the presence of meaning (how much a person feels their life has meaning) and the search for meaning (how much a person strives to find meaning and understanding in their life). The two sub-scale measures, which consist of 10 items on a 7-point Likert scale, range from 1-absolutely true to 7-absolutely untrue: five items for presence of meaning (POM) and five items for search for meaning (SFM). An SFM score of \< 24 indicates the person is not seeking meaning in their life.
Outcome measures
| Measure |
Life Story Book Intervention
n=21 Participants
Participants who received the Life Story Book intervention in either the first three weeks or the last three weeks of the study.
|
Usual Care
n=21 Participants
Participants who received Usual Care in either the first or last 3 weeks of the study.
|
|---|---|---|
|
Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Search for Meaning (SFM) at 3 Weeks
|
-2.62 score on a scale
Standard Deviation 10.11
|
12.24 score on a scale
Standard Deviation 13.11
|
Adverse Events
Life Story Book Intervention
Usual Care Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place