ENRICH Study: A Mixed-methods Feasibility Study of a Nurse-led Model of Care for Social Frailty in Philippine Primary Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe Hong Kong Polytechnic University

About this trial

The ENRICH Study is a single-arm, single-site, mixed-methods feasibility and pilot implementation study examining a culturally adapted, nurse-led model of care for social frailty among community-dwelling older adults in one primary health center in Manila City, Philippines.

The study comprises four sequential phases: (1) Filipino translation and cultural adaptation of the Montayre Social Frailty-10 (MSF-10); (2) participatory co-design and refinement of the Social Frailty Care Bundle (SFCB); (3) nurse training and competency assessment; and (4) a three-month pilot implementation. It will assess feasibility, acceptability, fidelity, workflow fit, recruitment, retention, follow-up completion, and implementation readiness to inform a future definitive trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 60 years or older

Filipino

Able to understand Filipino, either in written form or when read aloud

Community-dwelling (not living in an institution)

Disqualifiers

Living in an institution.

Receiving palliative or end-of-life care for which the intervention would not be appropriate.

Unable to demonstrate basic understanding of the study after explanation and teach-back.

Known moderate-to-severe cognitive impairment or dementia documented in clinical or health center records.

Trial design

Design model

Single group

Treatments tested in this trial

  • Group activities (i.e., low impact exercise), peer counseling, volunteering

    Other intervention

    The interventions are multidimensional and comes in bundle as needed we call it Social Frailty Bundle of Care.

  • Social Frailty Care Bundle (SFCB)

    Behavioral

    A structured nurse-led pathway delivered by trained registered nurses at the health center, in addition to usual care, over 3 months: (1) screening with the Filipino Montayre Social Frailty 10 (MSF-10); (2) domain-based assessment across four social frailty domains (general resources, social resources, social behavior and activity, and self-management); (3) individualized care planning; (4) brief education or coaching using approved materials; (5) referral or linkage, when indicated, to existing health, social welfare, community, faith-based, senior citizens' organization, non-governmental, or local government services (for example, group physical activity or peer support); (6) follow-up contacts, approximately every 4 weeks for lower-intensity needs, with escalation to nurse-led case management for complex needs; and (7) documentation and fidelity monitoring. Bundle content is finalized through participatory co-design before implementation.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Nurse-led Social Frailty Care Bundle (SFCB)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Consent rate among eligible older adults

Percentage of eligible older adults approached who provide written informed consent to join the 3-month pilot of the nurse-led Social Frailty Care Bundle (SFCB). Calculated as the number who consent divided by the number of eligible older adults approached, reported with a 95% confidence interval. Pre-specified progression criterion (green): at least 60%.

Time frame
At approach for enrollment (Day 0)
2

Retention at 3-month follow-up

Percentage of enrolled older adults who complete the 3-month follow-up assessment. Calculated as the number completing the 3-month follow-up divided by the number enrolled, reported with a 95% confidence interval. Reasons for withdrawal and loss to follow-up will be recorded where available. Pre-specified progression criterion (green): at least 75%.

Time frame
3 months after baseline
3

Nurse training completion rate

Percentage of eligible registered nurses invited to the Evidence-based Nurse-led Risk-informed Intervention for Community-based Healthy Ageing (ENRICH) training who complete it before delivering the Social Frailty Care Bundle (SFCB). Calculated as the number of nurses completing training divided by the number of eligible nurses invited, reported with a 95% confidence interval. Pre-specified progression criterion (green): at least 70%.

Time frame
At the end of nurse training (Phase 3), before the 3-month pilot implementation begins
4

Fidelity of Social Frailty Care Bundle (SFCB) delivery

Percentage of required core SFCB components documented as delivered across all participant encounters, assessed with a structured SFCB fidelity checklist completed by the delivering nurse after each encounter; at least 20% of participant records will be audited against the checklist by the investigators. Core components: screening with the Filipino Montayre Social Frailty 10 (MSF-10), domain-based assessment, individualized care plan, approved education or coaching, referral or linkage when indicated, follow-up documentation, and safety or escalation documentation when needed. Calculated as components delivered divided by components required. Pre-specified progression criterion (green): at least 80%.

Time frame
From baseline to 3 months

Secondary outcomes

1

Social frailty risk score on the Filipino Montayre Social Frailty 10 (MSF-10)

Candidate clinical outcome summarized descriptively; effectiveness will not be tested. The Montayre Social Frailty 10 (MSF-10) is a 10-item social frailty screening tool, culturally adapted into Filipino in Phase 1. The score is the mean risk score across the 10 items, ranging from 1.00 (minimum) to 5.00 (maximum); higher scores indicate greater social frailty risk (worse outcome). A mean score \> 3.40 to ≤ 3.90 indicates social pre-frailty and \> 3.90 indicates social frailty. Score distributions, item-level missingness, and floor and ceiling effects will also be described.

Time frame
Baseline and 3 months
2

Percentage of screened older adults classified as socially pre-frail or socially frail

Number of older adults screened with the Filipino Montayre Social Frailty 10 (MSF-10) who are classified as socially pre-frail or socially frail, divided by the number screened. Only anonymous aggregate screening counts are retained for this measure.

Time frame
At screening (Day 0)
3

Participant adherence to core intervention contacts

Percentage of planned core Social Frailty Care Bundle (SFCB) contacts completed per participant, including the care-planning discussion and agreed follow-up contacts, based on nurse contact logs. Reasons for non-completion will be recorded where available.

Time frame
From baseline to 3 months
4

Uptake of referral or linkage actions

Percentage of referral, linkage, or signposting actions offered to participants that are taken up (service contacted or accessed), based on the study referral log and follow-up contacts. The number and type of referrals offered will also be reported.

Time frame
From baseline to 3 months

Other outcomes

Sponsors and contacts

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