Connecting Through Caregiving: Reappraising Intergeneration Relationships (CTC)

April 12, 2019 updated by: The Hong Kong Polytechnic University

Connecting Through Caregiving: Reappraising Intergeneration Relationships for Dementia Caregivers

The purpose of the present study is to examine the effects of perspective-taking reappraisals on the well-being of adult-child dementia caregivers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dementia caregiving presents a particular challenge wherein the adult child is parenting his or her parents. Facilitating relational insights, the key components of the Connecting Through Caregiving (CTC) intervention involves the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy of the care-recipient, 3) help-seeking, 4) balancing self-care and caring for others and 5) negotiating action plans. The CTC intervention is be evaluated against a basic skill training intervention consisting of scheduling pleasant events, communicating with the care recipient and other family members. Dementia caregivers providing at least 14 hours of care per week to a parent living with dementia are recruited and randomized into one the two conditions. The intervention lasts for six weeks for both conditions. Intervention in the first week consists of a home visit and a telephone follow-up. From the second to fifth week, there are weekly four telephone phone sessions. In the sixth week, there were two more telephone calls to consolidate the intervention and to review implementation plans.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Recruiting
        • Institute of Active Ageing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The study participants will be primary caregivers aged 18 or older and who have been caring for persons (aged 60 or above) with a physician diagnosis of Alzheimer's disease in the mild to moderate range as determined by the Clinical Dementia Rating Scale.
  • Primary caregivers are those who have been providing unpaid care for more than 14 hours a week for at least the past three months.
  • The care should involve day-to-day decision-making as well as any of the following: feeding, dressing, bathing, toileting, housework, preparing meals, medication and handling finances.
  • They can be daughter/son or daughter-/son-in-law of the care recipients.

Exclusion Criteria:

  • Exclusion criteria are as follows: signs of severe intellectual deficits, demonstrated suicidal ideation, exhibited evidence of psychotic disorders, hearing/ visual impairment or inability to read or speak Chinese/Cantonese fluently and severe.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Connecting Through Caregiving
This arm focuses on perspective-taking reappraisal procedures.
Behavioral: Connecting Through Caregiving
The Connecting Through Caregiving intervention focuses on reappraisal exercises on intergeneration relationships in caregiving, involving the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy for the care-recipient, 3) help-seeking in caregiving, 4) balancing self-care and caring and 5) negotiating action plans.
Other: Basic Skills Building
This arm focuses on skill building.
Other: Basic Skills Building
Skill building involves: 1) monitoring activities, 2) pleasant event scheduling, 3) communicating with the care recipient, 4) communicating with family members and 5) review implementation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Life Satisfaction (LS): scale
Time Frame: Change from Baseline LS through study completion, an average of 2 months
Each response was rated from to 7 on each of the 5 items of the scale with higher score indicating higher level of life satisfaction
Change from Baseline LS through study completion, an average of 2 months
Change in Center for Epidemiologic Studies Depressive Scale (CESD)
Time Frame: Change from Baseline CESD through study completion, an average of 2 months
Each response was rated from 0 to 3 on a scale of the frequency of the occurrence of the symptom in the past week. Higher scores would suggest a higher
Change from Baseline CESD through study completion, an average of 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Zarit Burden Interview (ZBI)
Time Frame: Change from Baseline ZBI through study completion, an average of 2 months
Each of the 22 items required the caregiver to rate on a 5-point scale ranging from 0 (never) to 4 (nearly always).
Change from Baseline ZBI through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alma Au, {PhD, Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFC2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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