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Mental Health IssueNCT06127680

Brief Health Promotion Intervention for Older People in Mental Health

An observational study of Mental Health Issue and Frailty, run by University College Cork at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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: 1. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Mental Health Issue, Frailty
What is being tested?
Brief Health Promotion Advice
How many people
20 participants
Where
1 siteIreland
Study dates
1 Mar 2023to 30 Oct 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Older adult

Study population: 1. Service users with moderate advanced dementia will be excluded as the intervention is unsupervised. 2. Patents that cannot provide informed consent 3. Patients who cannot understand English or require a translator 4. Patients experience acute mental health crisis 5. Patients with significant restricted mobility, using Zimmer frame inside or outside their house (CFS≥5)

Who may be able to join

  • 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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • University College Cork

    Cork, Co Cork, T12 AK54.

Other trials in Ireland

About this study

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.

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:

Read more
  1. 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)
  2. Can older adults with ongoing mental health conditions be recruited and retained in the study
  3. Will participants adhere to the health promotion intervention over a three-month period
  4. 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).
Read the 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.

Being tested
Brief Health Promotion Advice
Keywords
Mental health, Older People, Health promotion, Exercise, Nutrition, Frailty
Medical subject headings
Frailty, Psychological Well-Being, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Health Promotion AdviceBehavioural

    Brief Health Promotion advice on exercise and nutrition (protein intake) delivered by a health care professional during routine consultations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SARC-F (tool title not an abbreviation)

    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).

    Measured: Baseline 3-month follow-up

Secondary outcomes (6)

  1. Clinical Frailty Scale

    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).

    Measured: Baseline and 3 months

  2. Global Physical Health Scale (GPHS) V1.2

    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)

    Measured: Baseline and 3 months

  3. Mental wellbeing (bespoke items)

    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

    Measured: Baseline and 3 months

  4. Yale Physical Assessment Scale

    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).

    Measured: Baseline and 3 months

  5. Simplified nutritional appetite questionnaire (SNAQ)

    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).

    Measured: Baseline and 3 months

  6. Protein intake

    Self-report number of protein portions eaten on previous day. Protein was categorised as: meat/fish; milk/diary; eggs/cheese; vegetable protein

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start1 Mar 2023
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion30 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06127680
Sponsor's protocol ID
ECM 4 (w) 14/02/2023
Status last verified
Nov 2023
First submitted
25 Sep 2023
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised individual patient data (IPD) will be available on request from the authors Data will include participant demographics and outcome measures listed above

Publications

  • Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.

    PubMed 33028215

  • Ida S, Kaneko R, Murata K. SARC-F for Screening of Sarcopenia Among Older Adults: A Meta-analysis of Screening Test Accuracy. J Am Med Dir Assoc. 2018 Aug;19(8):685-689. doi: 10.1016/j.jamda.2018.04.001. Epub 2018 May 31.

    PubMed 29778639

  • Pearson E, Siskind D, Hubbard RE, Gordon EH, Coulson EJ, Warren N. Frailty and severe mental illness: A systematic review and narrative synthesis. J Psychiatr Res. 2022 Mar;147:166-175. doi: 10.1016/j.jpsychires.2022.01.014. Epub 2022 Jan 8.

    PubMed 35051715

  • Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.

    PubMed 23810110

  • Hays RD, Spritzer KL, Thompson WW, Cella D. U.S. General Population Estimate for "Excellent" to "Poor" Self-Rated Health Item. J Gen Intern Med. 2015 Oct;30(10):1511-6. doi: 10.1007/s11606-015-3290-x. Epub 2015 Apr 2.

    PubMed 25832617

  • Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

    PubMed 20685078

  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PubMed 16129869

  • Travers J, Romero-Ortuno R, Cooney MT. Testing the feasibility of a primary-care exercise intervention to prevent and reverse early frailty and build resilience in community-dwelling older adults. EClinicalMedicine. 2022 Mar 22;46:101355. doi: 10.1016/j.eclinm.2022.101355. eCollection 2022 Apr.

    PubMed 35340628

  • PROMIS (2021) GLOBAL HEALTH SCORING. MANUALhttps://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Global_Health_Scoring_Manual.pdf

  • Malmstrom TK, Miller DK, Simonsick EM, Ferrucci L, Morley JE. SARC-F: a symptom score to predict persons with sarcopenia at risk for poor functional outcomes. J Cachexia Sarcopenia Muscle. 2016 Mar;7(1):28-36. doi: 10.1002/jcsm.12048. Epub 2015 Jul 7.

    PubMed 27066316

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health Issue and Frailty, run by University College Cork at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARC-F (tool title not an abbreviation) (time frame: Baseline 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06127680, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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