Clinical trial NCT06127680: Brief Health Promotion Intervention for Older People in Mental Health
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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mental Health Issue
Frailty
Keywords: Mental health
Older People
Health promotion
Exercise
Nutrition
Frailty
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

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:

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).

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.

Eligibility criteria: Inclusion Criteria:

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

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

     Exclusion Criteria:

Primary outcomes:
measure: SARC-F (tool title not an abbreviation)
timeFrame: Baseline 3-month follow-up
Secondary outcomes:
measure: Clinical Frailty Scale
timeFrame: Baseline and 3 months
measure: Global Physical Health Scale (GPHS) V1.2
timeFrame: Baseline and 3 months
measure: Mental wellbeing (bespoke items)
timeFrame: Baseline and 3 months
measure: Yale Physical Assessment Scale
timeFrame: Baseline and 3 months
measure: Simplified nutritional appetite questionnaire (SNAQ)
timeFrame: Baseline and 3 months
measure: Protein intake
timeFrame: Baseline and 3 months
Other outcomes:
measure: Acceptability (Bespoke item)
timeFrame: 1 and 3 month follow-up
measure: Ease of Use (Bespoke item)
timeFrame: 1 and 3 month follow-up
measure: Recommend to others (bespoke item)
timeFrame: 3 month follow-up
Locations:
city: Cork
country: Ireland
facility: University College Cork
state: Co Cork
Study officials:
affiliation: University College Cork
name: Corina Naughton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: PROMIS (2021) GLOBAL HEALTH SCORING. MANUALhttps://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Global_Health_Scoring_Manual.pdf
citation: 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.