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A Home-based Training Program for Elderly Patients With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02667951
Recruitment Status : Completed
First Posted : January 29, 2016
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Yea-Ing Lotus Shyu, Chang Gung Memorial Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Dementia
Intervention Other: A home-based caregiver-training program
Enrollment 129
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

Period Title: Overall Study
Started 66 63
Completed 45 40
Not Completed 21 23
Arm/Group Title Control Group Intervention Group Total
Hide Arm/Group Description Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

Total of all reporting groups
Overall Number of Baseline Participants 66 63 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 63 participants 129 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
  72.7%
47
  74.6%
95
  73.6%
>=65 years
18
  27.3%
16
  25.4%
34
  26.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 66 participants 63 participants 129 participants
56  (12) 55  (15) 55  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 63 participants 129 participants
Female
48
  72.7%
14
  22.2%
62
  48.1%
Male
18
  27.3%
49
  77.8%
67
  51.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Caregivers' Self-efficacy
Hide Description The Agitation Management Self-efficacy Scale was used to measure caregivers' self-efficacy for managing dementia patients' agitation. Caregivers were asked how confident they were about handling the problem for each identified behavioral problem and if they believed that they could manage the problem for behaviors that did not occur. Scores range from 42 to 210, with higher scores representing greater caregiver self-efficacy. In this study, Cronbach's alphas ranged from 0.98 to 0.99 at different time points.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

Overall Number of Participants Analyzed 45 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
155  (34) 178  (26)
2.Primary Outcome
Title Caregivers' Preparedness
Hide Description Preparedness was measured by the 10-item Caregiver Preparedness Scale,asks caregivers to rate how well prepared they think they are for seven domains of caregiving. A final question asks for an overall rating of how well prepared caregivers think they are to care for the care receiver. Items are scored on a 5-point Likert scale from 1 (not prepared) to 5 (well prepared). Scores range from 10 to 50, with higher scores representing greater preparedness for caregiving tasks. Validity and reliability of the original Preparedness scale was supported.24 The content validity index for the Preparedness Scale Taiwanese version was 1.0 and Cronbach's alpha for this scale among Taiwanese caregivers was 0.87. Cronbach's alpha in this study was 0.92.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

Overall Number of Participants Analyzed 45 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
33  (8) 38  (6)
3.Primary Outcome
Title Caregivers' Competence
Hide Description A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

Overall Number of Participants Analyzed 45 40
Mean (Standard Error)
Unit of Measure: units on a scale
51  (13) 66  (8)
4.Primary Outcome
Title Dementia Patients' Behavioral Problems
Hide Description Physically aggressive behaviors of dementia patients were measured by the PAB subscale of the Chinese version CMAI, community form, which was shown to be valid and reliable for a Taiwanese sample. Each item (behavioral problem) is scored according to its frequency from 1 (never happens) to 7 (several times per hour). PAB subscale scores range from 7 to 49, with higher scores indicating more physically aggressive behaviors. In this study, the PAB subscale had Cronbach's alpha of 0.55.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

Overall Number of Participants Analyzed 45 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.89  (1.66) 7.88  (1.91)
5.Secondary Outcome
Title Caregivers' Quality of Life
Hide Description The Taiwan version of the Medical Outcomes SF-36 was used to measure family caregivers' HRQoL. The SF-36 contains eight generic health concepts: physical functioning (PF), role disability due to physical health problems (RP); bodily pain (BP); vitality (energy/fatigue) (VT); general health perceptions (GH); role disability due to emotional problems (RE); social functioning (SF); and general mental health (MH). Taiwan-specific SF-36 algorithms were used to compute the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores using norm-based (mean = 50, SD = 10) scoring methods. Scores for each scale range from 0 to 100, with higher scores representing better health outcomes. In this study, Cronbach's alphas for the eight scales ranged from 0.81 to 0.99.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

Overall Number of Participants Analyzed 45 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
PF 80.22  (23.48) 83.38  (26.00)
RP 67.22  (47.02) 73.13  (43.63)
RE 70.37  (45.07) 88.33  (29.77)
SF 68.06  (28.27) 87.50  (17.68)
BP 72.84  (25.09) 82.25  (18.75)
VT 52.00  (21.52) 69.75  (13.77)
MH 64.09  (21.65) 72.50  (13.07)
GH 50.64  (27.43) 63.75  (22.22)
PCS 51.39  (9.72) 52.96  (10.64)
MCS 50.10  (10.92) 57.85  (7.11)
6.Secondary Outcome
Title Caregivers' Depressive Symptoms
Hide Description A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

Overall Number of Participants Analyzed 45 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
13  (12) 8  (7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.

Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.

All-Cause Mortality
Control Group Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Control Group Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/66 (0.00%)   0/63 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/66 (0.00%)   0/63 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Yea-Ing L. Shyu
Organization: School of Nursing, College of Medicine, Chang Gung University, Taoyuan, Taiwan
Phone: +886-3-211 8800 ext 5275
EMail: yeaing@mail.cgu.edu.tw
Layout table for additonal information
Responsible Party: Yea-Ing Lotus Shyu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02667951    
Other Study ID Numbers: NSC 97-2420-H-182-002-MY3
First Submitted: January 23, 2016
First Posted: January 29, 2016
Results First Submitted: February 2, 2017
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020