Trial Outcomes & Findings for A Home-based Training Program for Elderly Patients With Dementia (NCT NCT02667951)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

129 participants

Primary outcome timeframe

18 months

Results posted on

2023-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group 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.	Intervention Group 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 Study STARTED	66	63
Overall Study COMPLETED	45	40
Overall Study NOT COMPLETED	21	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=66 Participants 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.	Intervention Group n=63 Participants 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 n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=66 Participants	0 Participants n=63 Participants	0 Participants n=129 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=66 Participants	47 Participants n=63 Participants	95 Participants n=129 Participants
Age, Categorical >=65 years	18 Participants n=66 Participants	16 Participants n=63 Participants	34 Participants n=129 Participants
Age, Continuous	56 year STANDARD_DEVIATION 12 • n=66 Participants	55 year STANDARD_DEVIATION 15 • n=63 Participants	55 year STANDARD_DEVIATION 14 • n=129 Participants
Sex: Female, Male Female	48 Participants n=66 Participants	14 Participants n=63 Participants	62 Participants n=129 Participants
Sex: Female, Male Male	18 Participants n=66 Participants	49 Participants n=63 Participants	67 Participants n=129 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 18 months

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.

Outcome measures

Outcome measures
Measure	Control Group n=45 Participants 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.	Intervention Group n=40 Participants 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.
Caregivers' Self-efficacy	155 units on a scale Standard Deviation 34	178 units on a scale Standard Deviation 26

PRIMARY outcome

Timeframe: 18 months

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.

Outcome measures

Outcome measures
Measure	Control Group n=45 Participants 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.	Intervention Group n=40 Participants 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.
Caregivers' Preparedness	33 units on a scale Standard Deviation 8	38 units on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: 18 months

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.

Outcome measures

Outcome measures
Measure	Control Group n=45 Participants 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.	Intervention Group n=40 Participants 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.
Caregivers' Competence	51 units on a scale Standard Error 13	66 units on a scale Standard Error 8

PRIMARY outcome

Timeframe: 18 months

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.

Outcome measures

Outcome measures
Measure	Control Group n=45 Participants 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.	Intervention Group n=40 Participants 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.
Dementia Patients' Behavioral Problems	7.89 units on a scale Standard Deviation 1.66	7.88 units on a scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: 18 months

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.

Outcome measures

Outcome measures
Measure	Control Group n=45 Participants 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.	Intervention Group n=40 Participants 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.
Caregivers' Quality of Life PF	80.22 units on a scale Standard Deviation 23.48	83.38 units on a scale Standard Deviation 26.00
Caregivers' Quality of Life RE	70.37 units on a scale Standard Deviation 45.07	88.33 units on a scale Standard Deviation 29.77
Caregivers' Quality of Life GH	50.64 units on a scale Standard Deviation 27.43	63.75 units on a scale Standard Deviation 22.22
Caregivers' Quality of Life PCS	51.39 units on a scale Standard Deviation 9.72	52.96 units on a scale Standard Deviation 10.64
Caregivers' Quality of Life RP	67.22 units on a scale Standard Deviation 47.02	73.13 units on a scale Standard Deviation 43.63
Caregivers' Quality of Life SF	68.06 units on a scale Standard Deviation 28.27	87.50 units on a scale Standard Deviation 17.68
Caregivers' Quality of Life BP	72.84 units on a scale Standard Deviation 25.09	82.25 units on a scale Standard Deviation 18.75
Caregivers' Quality of Life VT	52.00 units on a scale Standard Deviation 21.52	69.75 units on a scale Standard Deviation 13.77
Caregivers' Quality of Life MH	64.09 units on a scale Standard Deviation 21.65	72.50 units on a scale Standard Deviation 13.07
Caregivers' Quality of Life MCS	50.10 units on a scale Standard Deviation 10.92	57.85 units on a scale Standard Deviation 7.11

SECONDARY outcome

Timeframe: 18 months

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.

Outcome measures

Outcome measures
Measure	Control Group n=45 Participants 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.	Intervention Group n=40 Participants 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.
Caregivers' Depressive Symptoms	13 units on a scale Standard Deviation 12	8 units on a scale Standard Deviation 7

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yea-Ing L. Shyu

School of Nursing, College of Medicine, Chang Gung University, Taoyuan, Taiwan

Phone: +886-3-211 8800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place