Brief Health Promotion Intervention for Older People in Mental Health

Sponsor

University College Cork (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06127680

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to test the delivery of brief health promotion advice with supporting information leaflets as part of standard clinical consultation for older people attending a community mental health service

The main questions it aims to answer are:

Is a brief health promotion intervention designed for primary care transferable and acceptable to older people attending acute community-based mental health services (Travers et al 2022)
Can older adults with ongoing mental health conditions be recruited and retained in the study
Will participants adhere to the health promotion intervention over a three-month period
Can evaluation data be collected from participants

Eligible participants will be asked to:

participate in a brief health promotion (10 minutes) advice given by an advanced nurse practitioner (ANP) in mental health during a routine outpatient clinic/home visit
participants receive exercise and protein advice leaflets (laminated)
participants rehearse the exercise with the ANP
one-month follow-up by ANP to assess and promote adherence to the intervention Researchers will use a one-group pre-post test study to compare baseline data on physical and mental health outcomes to participants' outcomes at three-month follow-up (there is no control group).

Condition or Disease	Intervention/Treatment	Phase
Mental Health Issue Frailty	Behavioral: Brief Health Promotion Advice

Detailed Description

Target Population

The target population is older adults attending mental health services aged 65 years and older. Age 65 years is the age for referral to older adult mental health services. The Older adult mental health services provide care and treatment for people aged over 65's who develop new onset functional mental illnesses such as depression, and severe anxiety or those with a diagnosis of dementia with behavioural and psychological problems requiring specialist intervention and care.

In the feasibility study Sample size, the aim is to recruit 15-20 patients to test the feasibility of the intervention in this population.

Study Design

The study will be a one-group pretest -posttest intervention design with a patient survey at baseline, 1-month and 3-month follow-up. The project will be undertaken over 12 months. Once ethical approval is obtained, patient recruitment and baseline data will be collected and the intervention will be delivered: in March - June 2023, 1 month follow-up April to July and three month follow-up August to October 2023.

Data Collection The ANP will complete the structured questionnaire with the patient in the MH clinic or patient home during routine clinical consultations. The one-month and three month follow-up will be via telephone or in the OPD clinic/persons' home as part of normal schedule of visits. No extra clinic or home visits are planned as part of the study.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Feasibility Study to Test the Implementation of Health Promotion Advice (Exercise and Protein Intake) for Older People Attending a Community Mental Health Service.

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Outcome Measures

Primary Outcome Measures

SARC-F (tool title not an abbreviation) [Baseline 3-month follow-up]
The SARC-F is a screening tool for sarcopenia (Malmstrom et al 2013). SARC-F comprises five components using self-report on: strength, assistance walking, rise from a chair, climb stairs, and falls. SARC-F scale scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst) and are dichotomized to represent symptomatic (4+) vs. healthy (0-3) status (Malmstrom et al 2016).

Secondary Outcome Measures

Clinical Frailty Scale [Baseline and 3 months]
Clinical Frailty Scale (CSF) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill), a higher score indicates poorer physical and cognitive function (Rockwood et al 2005, Church 2020).
Global Physical Health Scale (GPHS) V1.2 [Baseline and 3 months]
The Global Physical Health Scale v1.2 is a four-item validated general health questionnaire Riley et al 2010, Hays et al 2015). Four items are used to assess global physical health. Three items (rate your physical health, everyday activities , rate your fatigue ) of these are administered using five-category response scales. Higher scores indicated better health. One item (rating of pain on average) uses a response scale of 0-10 that is recoded to five categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5), the scale is then reverse coded, i.e. 0 (no pain)= 5). Overall scores range from 5 to 20 indicating best possible physical health (PROMIS 2021)
Mental wellbeing (bespoke items) [Baseline and 3 months]
Two items (rate your overall mental health, rate your mood/ sense of well-being) over past seven days was rated on a 5 point scale (excellent =5; very poor =1). Higher score indicates better mental health. Items are not combined for overall score
Yale Physical Assessment Scale [Baseline and 3 months]
Two items from Yale Physical Assessment Scale (vigorous exercise frequency and duration over past 7 days, and Walking for exercise frequency and duration over past 7 days ((De Abajo et al., 2001). Frequency was rated on a 4 point scale (not at all=0; 1-2 times=1, 3-4 times=2 or >4 times=3) Duration (0=not applicable, 1=10-30 mins, 2=31-60 mins, 3> 60 mins. Scores are calculated by multiplying Frequency score X Duration score (no weight was applied). Higher scores indicate more activity. Items were not combined for an overall exercise score. Post intervention, we added an additional question specific to the exercises on the information leaflet In the past week (7 days) have you completed the exercises on the information leaflet Frequency (None=0, 1 day=1, 2 days=2; 3 days=3, 4days=4, 5 days=5); X Duration (none =0; 10 mins=1, 11-20 mins=2 , 21-30 mins=3, >30 mins=4). Higher values indicate greater exercise intensity (min score 0 to 20).
Simplified nutritional appetite questionnaire (SNAQ) [Baseline and 3 months]
questionnaire (SNAQ) is a four item scale (rate appetite, When I eat I feel full, food tastes, normally I eat) are rated on a five point scale (1 to 5). Total possible score range from 5 to 20, higher scores indicate better appetite. SNAQ score 14 indicates significant risk of at least 5% weight loss within six months (Kruizenga et al., 2005).
Protein intake [Baseline and 3 months]
Self-report number of protein portions eaten on previous day. Protein was categorised as: meat/fish; milk/diary; eggs/cheese; vegetable protein

Other Outcome Measures

Acceptability (Bespoke item) [1 and 3 month follow-up]
One item measures acceptability: The exercise and nutrition advice was acceptable to me (made sense) rated on a 5 point Likert scale (1=strongly disagree to 5 strongly agree)
Ease of Use (Bespoke item) [1 and 3 month follow-up]
One item measured Ease of Use ' To what extent was it easy to incorporate the exercise an nutrition advice into your daily routine rated on a five point Likert scale (1=very difficult to 5 very easy)
Recommend to others (bespoke item) [3 month follow-up]
The final item sought participants opinion on 'recommending the intervention to others. 'In your opinion, should we continue to offer this advice and information leaflets to other people attending our service? With three response options Yes/No/ Don't know

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

For the purpose of this study service users eligible for the study are:

Aged 65 years and older
Cognitive capacity to provide informed consent
Attending Older adult mental health services
Mental Health team deem the client stable and able to participate in the intervention
Patient independently mobile and living in the community (may use a walk aid)(Clinical Frailty Scale ≤5)