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Community-based Multi-domain Intervention to Detect and Delay Cognitive Decline in Community-dwelling Older Adults: A Pilot Study

Not Applicable
Not yet recruiting
Conditions
Mild Cognitive Impairment
Mild Cognitive Impairment (MCI)
Registration Number
NCT07099040
Lead Sponsor
Singapore General Hospital
Brief Summary

The incidence of cognitive impairment and its burden are increasing with a rapidly ageing population. In Singapore, the prevalence of dementia among older adults aged 60 and above is approximately 10%, which will translate to approximately 152,000 older adults living with dementia by the year 2030. Using 2013 data as estimates, the total annual cost of dementia was already estimated at S$532 million while cost per person was estimated at S$10,245 per annum, and a further increase in corresponding costs is expected through 2030 with the projection of increase in persons with dementia (PWDs). There is thus an urgent need for (i) effective, scalable, and sustainable interventions that are widely accessible to detect and delay cognitive decline and frailty in our community-dwelling older adults, and (ii) providing support for their caregivers. This study aims to test the feasibility of a community-based multi-domain intervention for detecting and delaying cognitive impairment for the older population.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
170
Inclusion Criteria

Not provided

Exclusion Criteria

Older adults

  • Known diagnosis of moderate dementia and above,
  • Montreal Cognitive Assessment (MoCA) score <18,
  • Has difficulty in basic activities of daily living,
  • disorders that affects safe engagement in the intervention (e.g. symptomatic cardiovascular disease, revascularization within 1 year, major depression or anxiety with ongoing treatment, underlying malignancy),
  • Severe vision or hearing impairment or any other disorders preventing cooperation as judged by the study team,
  • Major illness with life expectancy <6 months,
  • Institutionalized,
  • Planned major surgery within the duration of the multi-domain intervention,
  • Physical disabilities that preclude study participation.

Caregivers:

  • aged below 21 years old,
  • not being the primary family caregiver of at least one older individual,
  • not being able to read, write, and converse in English/Mandarin,
  • their family members (older adults) have not participated in the pilot test for at least one month (1 session of cognitive activity/week, 2 sessions of physical activity/week).

Care providers:

  • not working for the older population,
  • Not being able to read, write, and converse in English/Mandarin,
  • have not provided service during the period of the pilot test for at least one month (1 session of cognitive activity/week, 2 sessions of physical activity/week).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Care recipients' cognition measured by the Montreal Cognitive Assessment (MoCA)From enrollment to the end of month 6

The MoCA (Montreal Cognitive Assessment) scoring ranges from 0 to 30, with a higher score indicates better cognitive function.

Secondary Outcome Measures
NameTimeMethod
Care recipients' physical function measured by short physical performance battery (SPPB)From enrollment to the end of month 6

The Short Physical Performance Battery (SPPB) assesses lower extremity function in older adults by evaluating standing balance, gait speed, and repeated chair stands, with scores ranging from 0 to 12, where higher scores indicate better function.

Care recipients' frailty measured by FRAIL scaleFrom enrollment to the end of month 6

The FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight) is a clinical screening tool used to identify frailty in older adults.

Scoring breakdown:

* Each component is scored as 0 or 1

* Minimum total score: 0

* Maximum total score: 5

Higher scores indicate worse outcomes/greater frailty:

The five components are scored as follows:

* Fatigue: "Are you fatigued?" (Yes = 1, No = 0)

* Resistance: "Can you climb one flight of stairs?" (No = 1, Yes = 0)

* Ambulation: "Can you walk one block?" (No = 1, Yes = 0)

* Illnesses: Having 5 or more illnesses (Yes = 1, No = 0)

* Loss of weight: \>5% weight loss in past 6 months (Yes = 1, No = 0)

Care recipients' health-related quality of life measured by EuroQol 5-Dimension 5-Level (EQ-5D-5L)From enrollment to the end of month 6

EuroQol 5-Dimension 5-Level (EQ-5D-5L)

For the individual dimension scores (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression):

* Minimum value: 1

* Maximum value: 5

* Higher scores = Worse health outcomes

Care recipients' health state on a EuroQol Visual Analogue Scale (EQ VAS)From enrollment to the end of month 6

For the EuroQol Visual Analogue Scale (EQ VAS):

* Minimum value: 0

* Maximum value: 100

* Higher scores = Better health outcomes

Caregivers' caregiving burden measured by Zarit burden interview (ZBI)From enrollment to the end of month 6

The Zarit Burden Interview-12 (ZBI-12) or Short Version of Zarit Burden Interview:

* Minimum score: 0

* Maximum score: 48

* Higher scores indicate greater caregiver burden

Scoring interpretation:

* 0-10: No to mild burden

* 11-20: Mild to moderate burden

* 20: High burden

Feasibility outcome - Care recipients' perceptions of the intervention, collected from qualitative interviewMonth 6
Feasibility outcome - Caregivers' perceptions of the intervention, collected from qualitative interviewMonth 6
Care recipients' ability to perform more complex tasks necessary for independent living within the community - Measured by Lawton scale iADLFrom enrollment to the end of month 6

Each item in iADL is rated based on the person's ability to perform the task independently, with some versions scoring:

0 = unable or needs help

1 = independent

Total scores range from 0 (low function, dependent) to 8 (high function, independent).

Feasibility outcome - Acceptability, collected from the Acceptability of Intervention Measure (AIM)From enrollment to the end of month 6

AIM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

1. - Completely disagree

2. - Disagree

3. - Neither agree nor disagree

4. - Agree

5. - Completely agree

Feasibility outcome - Perceived appropriateness, collected from the Intervention Appropriateness Measure (IAM)Month 6

IAM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

1. - Completely disagree

2. - Disagree

3. - Neither agree nor disagree

4. - Agree

5. - Completely agree

Feasibility outcome - Perceived feasibility, collected from the Feasibility of Intervention Measure (FIM)Month 6

FIM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

1. - Completely disagree

2. - Disagree

3. - Neither agree nor disagree

4. - Agree

5. - Completely agree

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