The HAPPI Study: Developing and testing an assessment and care plan to support older people who live with frailty at home

The Holistic Assessment and care Planning in Partnership Intervention (HAPPI) Study: A cluster randomised, controlled feasibility study of a nurse-led, holistic assessment and care planning intervention for older people living with frailty in primary care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74345449

Enrollment

Registered

2018-11-21

Start date

2018-12-01

Completion date

Unknown

Last updated

2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty in older people Signs and Symptoms Older people with frailty

Interventions

We aim to recruit 60 participants from general practices in Cornwall. Cluster randomisation will be used. Half of the general practices will be allocated to the intervention and half to the control ar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 65 years and over 2. Moderately frail: Electronic Frailty Index (eFI) >0.24 to 0.36 or severely frail (eFI >0.36) 3. Frailty confirmed by PRISMA7 instrument 4. Able to give informed consent 5. Living in own home or supported living accommodation

Exclusion criteria

Exclusion criteria: 1. Fit or mildly frail (eFI 0.13 – 0.24) 2. In receipt of palliative care, on gold standards framework register or where clinician feels they have limited life expectancy 3. Already on the caseload of a Community Matron

Design outcomes

Primary

Measure	Time frame
1. Feasibility of the intervention, assessed using the following after 3 and 6 months: 1.1. Numbers of completed HAPPI intervention conversation guides and personalised care plan templates 1.2. Degree of contamination by number of staff moving between intervention and control practices 2. Feasibility of conducting the trial, assessed using the following after 3 and 6 months: 2.1. Number of GP practices expressing an interest in participating 2.2. Number of GP practices screened for selection and reasons for non-selection 2.3. Number of GP practices withdrawing from the study, timing and reason for withdrawal 2.4. Number of GP practices failing to progress through implementation milestones and reasons for failure 2.5. Number of GP practices withdrawing during the implementation and delivery phases 2.6. Numbers of participants screened as eligible, recruited, consented and followed up 2.7. Numbers of participants identified using the electronic frailty index (eFI) 2.8. Number of and timing of participant withdrawals from follow-up data collection, reasons for withdrawal, number of and timing of losses to follow-up 3. Assessment of different potential and secondary outcomes of the future trial, assessed at the baseline and after 3 and 6 months: 3.1. Numbers of potential primary and secondary outcome measures completed 3.2. Numbers of missing items for each potential primary and secondary outcome 3.3. Estimation of the feasibility of collecting data to estimate cost-effectiveness (EQ-5D-5L, add-on for economic evaluation) 3.4. Assessment of the following outcome measure instruments: 3.4.1. Review of usual care practice, using a clinical note review of control participants 3.4.2. Level of care at home received measured by participant self-reporting 3.4.3. Polypharmacy – number of medications prescribed and participant perception of adverse effects 3.4.4. Number of falls measured by participant self-reporting 3.4.5. Levels of loneliness and isolation measured by UCLA 3	—

Measure

Time frame

1. Feasibility of the intervention, assessed using the following after 3 and 6 months: 1.1. Numbers of completed HAPPI intervention conversation guides and personalised care plan templates 1.2. Degree of contamination by number of staff moving between intervention and control practices 2. Feasibility of conducting the trial, assessed using the following after 3 and 6 months: 2.1. Number of GP practices expressing an interest in participating 2.2. Number of GP practices screened for selection and reasons for non-selection 2.3. Number of GP practices withdrawing from the study, timing and reason for withdrawal 2.4. Number of GP practices failing to progress through implementation milestones and reasons for failure 2.5. Number of GP practices withdrawing during the implementation and delivery phases 2.6. Numbers of participants screened as eligible, recruited, consented and followed up 2.7. Numbers of participants identified using the electronic frailty index (eFI) 2.8. Number of and timing of participant withdrawals from follow-up data collection, reasons for withdrawal, number of and timing of losses to follow-up 3. Assessment of different potential and secondary outcomes of the future trial, assessed at the baseline and after 3 and 6 months: 3.1. Numbers of potential primary and secondary outcome measures completed 3.2. Numbers of missing items for each potential primary and secondary outcome 3.3. Estimation of the feasibility of collecting data to estimate cost-effectiveness (EQ-5D-5L, add-on for economic evaluation) 3.4. Assessment of the following outcome measure instruments: 3.4.1. Review of usual care practice, using a clinical note review of control participants 3.4.2. Level of care at home received measured by participant self-reporting 3.4.3. Polypharmacy – number of medications prescribed and participant perception of adverse effects 3.4.4. Number of falls measured by participant self-reporting 3.4.5. Levels of loneliness and isolation measured by UCLA 3

—

Secondary

Measure	Time frame
Functional ability, assessed using the following at the baseline and after 3 and 6 months: 1. Barthel Index 2. 36-item Short Form Survey (SF-36)	—

Countries

England, United Kingdom

Contacts

Public ContactHelen Lyndon

helen.lyndon@plymouth.ac.uk07919891065

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026