NCT07037550

Brief Summary

In the realm of dementia care, the imperative to intervene at the earliest stages of cognitive decline is paramount. Recognizing this pivotal moment, the development of innovative and effective interventions becomes imperative in delaying dementia progression. Rooted in the Roy Adaptation Model and Zimmer's Theory of Psychological Empowerment, the investigator team has developed the empowerment-based dyadic strength-based intervention, which integrates strength-based and empowerment methodologies. Emphasizing a shift from deficits to capabilities, the strength-based approach fosters awareness of collective strengths within care dyads, facilitating coping mechanisms and resilience in the face of cognitive afflictions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jul 2024Jun 2026

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

dementiamild cognitive impairmentcaregiverstrength-based interventiondementia alzheimer type

Outcome Measures

Primary Outcomes (24)

  • A battery of cognitive assessments (CAB)

    evaluate the global cognition sore by the Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog), the digit span-forward and backward test for attention and working memory, the list learning delayed recall test for episodic memory, 5-min Montreal Cognitive Assessment and Trail-Making Test for complex attention, executive function and task switching. The higher score indicates poor cognitive function

    baseline (T0)

  • A battery of cognitive assessments (CAB)

    evaluate the global cognition sore by the Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog), the digit span-forward and backward test for attention and working memory, the list learning delayed recall test for episodic memory, 5-min Montreal Cognitive Assessment and Trail-Making Test for complex attention, executive function and task switching. The higher score indicates poor cognitive function

    9-weeks immediate posttest (T1)

  • A battery of cognitive assessments (CAB)

    evaluate the global cognition sore by the Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog), the digit span-forward and backward test for attention and working memory, the list learning delayed recall test for episodic memory, 5-min Montreal Cognitive Assessment and Trail-Making Test for complex attention, executive function and task switching. The higher score indicates poor cognitive function

    3 months after the posttest (T2)

  • Quality of Life-Alzheimer's Disease (QoL-AD)

    evaluate the health-related quality of life (HRQL) covering physical, functional, psychosocial, interpersonal, and environmental status of the patient with dementia, scales 13 to 52, with higher score indicating better HRQL

    baseline (T0)

  • Quality of Life-Alzheimer's Disease (QoL-AD)

    evaluate the health-related quality of life (HRQL) covering physical, functional, psychosocial, interpersonal, and environmental status of the patient with dementia, scales 13 to 52, with higher score indicating better HRQL

    9-weeks immediate posttest (T1)

  • Quality of Life-Alzheimer's Disease (QoL-AD)

    evaluate the health-related quality of life (HRQL) covering physical, functional, psychosocial, interpersonal, and environmental status of the patient with dementia, scales 13 to 52, with higher score indicating better HRQL

    3 months after the posttest (T2)

  • the 10-item Center for Epidemiologic Studies Depression Scale (CES-D)

    evaluate the changes in participant's mood status. The response set is a 4-point Likert scale, scale from 0-30, with a higher score indicating a higher level of depression.

    baseline (T0)

  • the 10-item Center for Epidemiologic Studies Depression Scale (CES-D)

    evaluate the changes in participant's mood status. The response set is a 4-point Likert scale, scale from 0-30, with a higher score indicating a higher level of depression.

    9-weeks immediate posttest (T1)

  • the 10-item Center for Epidemiologic Studies Depression Scale (CES-D)

    evaluate the changes in participant's mood status. The response set is a 4-point Likert scale, scale from 0-30, with a higher score indicating a higher level of depression.

    3 months after the posttest (T2)

  • Dyadic Relationship Scale - Patient version (DRS-patient)

    evaluate the quality of interpersonal relationships in the caregiving dyad, in the care recipient perspective. It measures aspects such as communication, support, and satisfaction within the dyad, providing insight into the dynamics of caregiving relationships in dementia care settings. It scale from 0-30 with a higher score indicating a better dyadic relationship.

    baseline (T0)

  • Dyadic Relationship Scale - Patient version (DRS-patient)

    evaluate the quality of interpersonal relationships in the caregiving dyad, in the care recipient perspective. It measures aspects such as communication, support, and satisfaction within the dyad, providing insight into the dynamics of caregiving relationships in dementia care settings. It scale from 0-30 with a higher score indicating a better dyadic relationship.

    9-weeks immediate posttest (T1)

  • Dyadic Relationship Scale - Patient version (DRS-patient)

    evaluate the quality of interpersonal relationships in the caregiving dyad, in the care recipient perspective. It measures aspects such as communication, support, and satisfaction within the dyad, providing insight into the dynamics of caregiving relationships in dementia care settings. It scale from 0-30 with a higher score indicating a better dyadic relationship.

    3 months after the posttest (T2)

  • Dyadic Relationship Scale - Caregiver version (DRS-caregiver)

    evaluate the quality of interpersonal relationships in the caregiving dyad, in the caregiver perspective. It measures aspects such as communication, support, and satisfaction within the dyad, providing insight into the dynamics of caregiving relationships in dementia care settings. It scale from 0-33 with a higher score indicating a better dyadic relationship.

    baseline (T0)

  • Dyadic Relationship Scale - Caregiver version (DRS-caregiver)

    evaluate the quality of interpersonal relationships in the caregiving dyad, in the caregiver perspective. It measures aspects such as communication, support, and satisfaction within the dyad, providing insight into the dynamics of caregiving relationships in dementia care settings. It scale from 0-33 with a higher score indicating a better dyadic relationship.

    9-weeks immediate posttest (T1)

  • Dyadic Relationship Scale - Caregiver version (DRS-caregiver)

    evaluate the quality of interpersonal relationships in the caregiving dyad, in the caregiver perspective. It measures aspects such as communication, support, and satisfaction within the dyad, providing insight into the dynamics of caregiving relationships in dementia care settings. It scale from 0-33 with a higher score indicating a better dyadic relationship.

    3 months after the posttest (T2)

  • The Revised Scale for Caregiving Self-Efficacy (RSCSE)

    evaluate the perceived self-efficacy in caregiving, to measure the caregivers' perceived self-efficacy in handling the symptoms of the persons with mild cognitive impairment and to control their own emotions. It scale from 0-100 with a higher score indicating a higher caregiving self-efficacy.

    baseline (T0)

  • The Revised Scale for Caregiving Self-Efficacy (RSCSE)

    evaluate the perceived self-efficacy in caregiving, to measure the caregivers' perceived self-efficacy in handling the symptoms of the persons with mild cognitive impairment and to control their own emotions. It scale from 0-100 with a higher score indicating a higher caregiving self-efficacy.

    9-weeks immediate posttest (T1)

  • The Revised Scale for Caregiving Self-Efficacy (RSCSE)

    evaluate the perceived self-efficacy in caregiving, to measure the caregivers' perceived self-efficacy in handling the symptoms of the persons with mild cognitive impairment and to control their own emotions. It scale from 0-100 with a higher score indicating a higher caregiving self-efficacy.

    3 months after the posttest (T2)

  • The Neuro-psychiatric Inventory (NPI)

    evaluate the neuro-psychiatric symptoms of the patient with dementia reported by the caregiver, scales from 12 to 96 with higher scores indicating higher severity

    baseline (T0)

  • The Neuro-psychiatric Inventory (NPI)

    evaluate the neuro-psychiatric symptoms of the patient with dementia reported by the caregiver, scales from 12 to 96 with higher scores indicating higher severity

    9-weeks immediate posttest (T1)

  • The Neuro-psychiatric Inventory (NPI)

    evaluate the neuro-psychiatric symptoms of the patient with dementia reported by the caregiver, scales from 12 to 96 with higher scores indicating higher severity

    3 months after the posttest (T2)

  • the Patient-Reported Mild Behavioral Impairment Scale

    evaluate the behavioral changes associated with cognitive decline for those with mild cognitive impairment, which enables patients to self-report symptoms, aiding in early detection and intervention for mild behavioral impairment, a potential precursor to dementia. It scale from 0-102 with a higher score indicating a higher risk of behavioral changes associated with cognitive decline.

    baseline (T0)

  • the Patient-Reported Mild Behavioral Impairment Scale

    evaluate the behavioral changes associated with cognitive decline for those with mild cognitive impairment, which enables patients to self-report symptoms, aiding in early detection and intervention for mild behavioral impairment, a potential precursor to dementia. It scale from 0-102 with a higher score indicating a higher risk of behavioral changes associated with cognitive decline.

    9-weeks immediate posttest (T1)

  • the Patient-Reported Mild Behavioral Impairment Scale

    evaluate the behavioral changes associated with cognitive decline for those with mild cognitive impairment, which enables patients to self-report symptoms, aiding in early detection and intervention for mild behavioral impairment, a potential precursor to dementia. It scale from 0-102 with a higher score indicating a higher risk of behavioral changes associated with cognitive decline.

    3 months after the posttest (T2)

Study Arms (2)

Strength-based intervention

EXPERIMENTAL

The Strength-based intervention incorporates 8-week Ambassador-led strength-based intervention including: a strength-based assessment to the patient-participant and caregiver done by the Social Worker, Ambassador-assisted preparation of the strength-based biography, four Ambassador-led workshops, the workshop will be delivered in group of 6-8 participants by at least 2 Ambassadors, and one Social Worker-led zoom video conference delivered to the caregivers.

Behavioral: Strength-based intervention

Usual care

NO INTERVENTION

No intervention, continue with usual care

Interventions

The Strength-based intervention incorporates 8-week Ambassador-led strength-based intervention including: 1. a strength-based assessment to the patient-participant and caregiver done by the Social Worker, 2. Ambassador-assisted preparation of the strength-based biography, 3. four Ambassador-led workshops, the workshop will be delivered in group of 6-8 participants by at least 2 Ambassadors, and 4. one Social Worker-led zoom video conference delivered to the caregivers.

Strength-based intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 18
  • a confirmed diagnosis of mild dementia as indicated by the cut-off score of Montreal Cognitive Assessment-5-min at 13-18 for dementia and \>18-21 for mild cognitive impairment
  • self-reported cognitive complaints
  • have the ability to engage in the communication with the research assistant
  • able to identify a family caregiver
  • consent to participate

You may not qualify if:

  • person who has communication problems with the research team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

Related Publications (9)

  • Haskan Avcı, Òˆ. (2014). Development of the Dyadic Relationship Scale. Eurasian Journal of Educational Research, 56, 89-108 DOI: http://dx.doi.org/10.14689/ejer.2014.56.6

    BACKGROUND
  • Yu DS, Li PW, Zhang F, Cheng ST, Ng TK, Judge KS. The effects of a dyadic strength-based empowerment program on the health outcomes of people with mild cognitive impairment and their family caregivers: a randomized controlled trial. Clin Interv Aging. 2019 Oct 4;14:1705-1717. doi: 10.2147/CIA.S213006. eCollection 2019.

    PMID: 31686796BACKGROUND
  • Yeung PY, Wong LLL, Chan CC, Yung CY, Leung LMJ, Tam YY, Tang LN, Li HS, Lau ML. Montreal Cognitive Assessment - Single Cutoff Achieves Screening Purpose. Neuropsychiatr Dis Treat. 2020 Nov 6;16:2681-2687. doi: 10.2147/NDT.S269243. eCollection 2020.

    PMID: 33192067BACKGROUND
  • Smith SC, Lamping DL, Banerjee S, Harwood R, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Measurement of health-related quality of life for people with dementia: development of a new instrument (DEMQOL) and an evaluation of current methodology. Health Technol Assess. 2005 Mar;9(10):1-93, iii-iv. doi: 10.3310/hta9100.

    PMID: 15774233BACKGROUND
  • Ismail Z, Aguera-Ortiz L, Brodaty H, Cieslak A, Cummings J, Fischer CE, Gauthier S, Geda YE, Herrmann N, Kanji J, Lanctot KL, Miller DS, Mortby ME, Onyike CU, Rosenberg PB, Smith EE, Smith GS, Sultzer DL, Lyketsos C; NPS Professional Interest Area of the International Society of to Advance Alzheimer's Research and Treatment (NPS-PIA of ISTAART). The Mild Behavioral Impairment Checklist (MBI-C): A Rating Scale for Neuropsychiatric Symptoms in Pre-Dementia Populations. J Alzheimers Dis. 2017;56(3):929-938. doi: 10.3233/JAD-160979.

    PMID: 28059789BACKGROUND
  • Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

    PMID: 7991117BACKGROUND
  • Chu LW, Chiu KC, Hui SL, Yu GK, Tsui WJ, Lee PW. The reliability and validity of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad Med Singap. 2000 Jul;29(4):474-85.

    PMID: 11056778BACKGROUND
  • Boey KW. Cross-validation of a short form of the CES-D in Chinese elderly. Int J Geriatr Psychiatry. 1999 Aug;14(8):608-17. doi: 10.1002/(sici)1099-1166(199908)14:83.0.co;2-z.

    PMID: 10489651BACKGROUND
  • Steffen AM, Gallagher-Thompson D, Arenella KM, Au A, Cheng ST, Crespo M, Cristancho-Lacroix V, Lopez J, Losada-Baltar A, Marquez-Gonzalez M, Nogales-Gonzalez C, Romero-Moreno R. Validating the Revised Scale for Caregiving Self-Efficacy: A Cross-National Review. Gerontologist. 2019 Jul 16;59(4):e325-e342. doi: 10.1093/geront/gny004.

    PMID: 29546334BACKGROUND

MeSH Terms

Conditions

DementiaCognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersTauopathiesNeurodegenerative Diseases

Central Study Contacts

Sau Fung Doris Yu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Another Research Assistant with no information of the random group allocation will execute the posttest assessment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The Strength-based intervention incorporates 8-week Ambassador-led strength-based intervention including: 1. a strength-based assessment to the patient-participant and caregiver done by the Social Worker, 2. Ambassador-assisted preparation of the strength-based biography, 3. four Ambassador-led workshops, the workshop will be delivered in group of 6-8 participants by at least 2 Ambassadors, and 4. one Social Worker-led zoom video conference delivered to the caregivers.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

July 1, 2024

Primary Completion

January 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data (IPD) available.

Locations