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DementiaNCT03378050

A Trial of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia

A study testing HEART in people with Dementia, run by Yale University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is the first randomized controlled trial exploring the implementation of a multi-component individualized telephone-based support intervention for adult-child caregivers caring for parents with dementia in China. Results hold the potential to inform the further development of family caregiver supportive services. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dementia
What is being tested?
HEART
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2018to Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary caregivers being adult children (age 18 or older) who have spent at least 2 hours per day over the last 3 months caring for a parent with a diagnosis of dementia.
  • Must have telephone access.
  • Caregivers will not end their primary caregiving role within 6 months of study enrollment.

Who cannot join

  • Cognitive impairment or intellectual disability.
  • Those who are providing care for another relative with chronic physical or mental diseases.
  • Pregnant women (Because it is unlikely that this group would be primary caregivers except in exceptional circumstances, the consideration of which was beyond the scope of this research).

About this study

Official title: Efficacy and Feasibility of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia in China: Study Protocol of a Randomized Controlled Trial

This is the first randomized controlled trial exploring the implementation of a multi-component individualized telephone-based support intervention for adult-child caregivers caring for parents with dementia in China. Results hold the potential to inform the further development of family caregiver supportive services.

Read the detailed description

The objectives of this study are to evaluate the efficacy and feasibility of a multi-component individualized telephone-based support intervention (HEART) for adult-child caregivers caring for parents with dementia in China.

The primary hypothesis to test is whether the HEART is more efficacious in reducing caregiver burden than the follow-up as usual (FU) in dementia adult-child caregivers.

Secondary hypotheses include the following:

  1. The HEART is more efficacious in improving health related quality of life than the FU in dementia adult-child caregivers.
  2. The HEART is more efficacious in protecting reciprocal Filial Piety than the FU in dementia adult-child caregivers.
  3. The HEART is more efficacious in relieving CR's behavioral and psychological symptoms of dementia (BPSD) than the FU in dementia adult-child caregivers.
  4. The HEART group has a higher satisfaction with the intervention than the FU group.

In addition, two research questions will be answered by qualitative data from process evaluation for the feasibility of the HEART intervention. The research questions are as follows:

  1. To what extent can the HEART intervention be delivered as planned?
  2. What are the barriers to and facilitators of the HEART intervention?
Conditions
Dementia
Being tested
HEART, Usual Care
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEARTBehavioural

    The intervention group will receive a multi-component individualized support intervention "HEART", which will consist of 12 sessions in four stages. By using a comprehensive assessment targeting five components, an individualized intervention plan will be developed to address identified problems and unmet needs. Those five components consist of: Health, Emotion, Activities, Resources and Training.

  • Usual CareOther

    Caregivers in the control group will receive 12 week follow-up as usual (FU) including two brief "check-in" calls and an outcome measures call during the study period.

Study groups in NCT03378050
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention group will receive a multi-component individualized support intervention "HEART", which will consist of 12 sessions in four stages.
Receives: Behavioral: HEART
Control groupActive comparatorParticipants is the control group will be placed on a waiting list for 12 weeks. They will receive the intervention, after they complete the 12-week follow-up assessment. Caregivers in the control group will receive 12 week follow-up as usual (FU) including two brief "check-in" calls and an outcome measures call during the study period.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregiver Burden

    Caregiver burden will be assessed using the 12-item version of Zarit Burden Interview (12-item ZBI) to measure caregiver burden (Bédard, 2001; Zarit, 1980). Each item is rated on a 5-point Likert scale from 0 (never) though 4 (nearly always), yielding a possible range of 0 to 48. Higher scores indicate greater levels of caregiver burden. This short version and The Chinese version of 12-item ZBI has excellent internal consistency (Cronbachα= 0.87); and is highly correlated with the full measure (r = 0.952) (Lin, 2017; Wang, Yand, \& Hou, 2006).

    Measured: 12 weeks

Secondary outcomes (5)

  1. Caregiver Burden

    Caregiver burden will be assessed using the 12-item version of Zarit Burden Interview (12-item ZBI) to measure caregiver burden (Bédard, 2001; Zarit, 1980). Each item is rated on a 5-point Likert scale from 0 (never) though 4 (nearly always), yielding a possible range of 0 to 48. Higher scores indicate greater levels of caregiver burden. This short version and The Chinese version of 12-item ZBI has excellent internal consistency (Cronbachα= 0.87); and is highly correlated with the full measure (r = 0.952) (Lin, 2017; Wang, Yand, \& Hou, 2006).

    Measured: Baseline, 6 weeks and 24 weeks

  2. Health Related Quality of Life

    HRQoL will be measured using the 12-item Short Form Health Survey (SF-12), which is wildly used and has proved its feasibility in both self-administered and telephone interview (Lungenhausen et al., 2007; Ware Jr, Kosinski, \& Keller, 1996). SF-12 consists of the mental component summary (MCS) and the physical component summary (PCS) with scores ranging from 0 to 100. Higher scores correspond to higher HRQoL. The Chinese version of SF-12 has been proved satisfactory for measuring and evaluating the quality of life for Chinese (Lam, Eileen, \& Gandek, 2005).

    Measured: Baseline, 6 weeks, 12 weeks and 24 weeks

  3. Reciprocal Filial Piety

    The 8-item Reciprocal Filial Piety Scale (RFPS) (Yeh and Bedford, 2003) will used to measure RFP of adult children caring for their parents. This instrument uses a 5-point Likert scale from 1 (strongly disagree) to 6(strongly agree), yielding a total RFPS ranging from 8 to 48. Higher scores indicate greater RFP. Coefficient (Cronbach) α for RFPS was 0.92, suggesting excellent reliability in this sample.

    Measured: Baseline, 6 weeks, 12 weeks and 24 weeks

  4. BPSD

    Caregivers' behavioral symptoms and caregivers' behavior-related reactions will be measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) (Kaufer et al., 2000), which covers 12 neuropsychiatric symptom domains. A "yes" or "no" screening question is used for each of the symptom. If the answer is "yes", caregivers are asked to rate the severity and distress of the symptoms in the last 4 weeks. The severity of the symptom is assessed in terms of on 3-point scale (1-mild, 2-moderate, 3-severe), yielding a possible range of 0 to 36. Caregiver distress associated with the symptom is rated by a 5-point Likert scale from 1 (mild) to 5(extreme), yielding a possible range of 0 to 60. The psychometric properties of English and Chinese versions are validated (Kaufer et al., 2000; Xie, Wang, \& Yu, 2005).

    Measured: Baseline, 6 weeks, 12 weeks and 24 weeks

  5. Satisfaction with and benefits from the Intervention

    Caregivers will complete 8 questions about their satisfaction and benefits from participating in the study at the conclusion of the study. The measure uses a 5-point Likert scale from 1 (not at all) to 5(a great deal), yielding a total score ranging from 8 to 40.

    Measured: 12 weeks and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2017
  2. Study startSep 2018 (estimated)
  3. Primary completionJan 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Why it stopped: Study Never Began

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, controlled trial (RCT) will be used to compare a 12-week intervention group with a waiting-list control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378050
Sponsor's protocol ID
Yu12.17
Status last verified
Apr 2021
First submitted
14 Dec 2017
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing HEART in people with Dementia, run by Yale University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver Burden (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03378050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.

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