NCT06127680

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:

  • 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

September 25, 2023

Last Update Submit

November 7, 2023

Conditions

Keywords

Mental healthOlder PeopleHealth promotionExerciseNutritionFrailty

Outcome Measures

Primary Outcomes (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).

    Baseline 3-month follow-up

Secondary Outcomes (6)

  • Clinical Frailty Scale

    Baseline and 3 months

  • Global Physical Health Scale (GPHS) V1.2

    Baseline and 3 months

  • Mental wellbeing (bespoke items)

    Baseline and 3 months

  • Yale Physical Assessment Scale

    Baseline and 3 months

  • Simplified nutritional appetite questionnaire (SNAQ)

    Baseline and 3 months

  • +1 more secondary outcomes

Other Outcomes (3)

  • Acceptability (Bespoke item)

    1 and 3 month follow-up

  • Ease of Use (Bespoke item)

    1 and 3 month follow-up

  • Recommend to others (bespoke item)

    3 month follow-up

Interventions

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

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Cork

Cork, Co Cork, T12 AK54., Ireland

Location

Related Publications (10)

  • 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.

    PMID: 33028215BACKGROUND
  • 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.

    PMID: 29778639BACKGROUND
  • 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.

    PMID: 35051715BACKGROUND
  • 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.

    PMID: 23810110BACKGROUND
  • 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.

    PMID: 25832617BACKGROUND
  • 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.

    PMID: 20685078BACKGROUND
  • 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.

    PMID: 16129869BACKGROUND
  • 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.

    PMID: 35340628BACKGROUND
  • PROMIS (2021) GLOBAL HEALTH SCORING. MANUALhttps://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Global_Health_Scoring_Manual.pdf

    BACKGROUND
  • 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.

    PMID: 27066316BACKGROUND

MeSH Terms

Conditions

FrailtyPsychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Corina Naughton, PhD

    University College Cork

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Corina Naughton

Study Record Dates

First Submitted

September 25, 2023

First Posted

November 13, 2023

Study Start

March 1, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Anonymised individual patient data (IPD) will be available on request from the authors Data will include participant demographics and outcome measures listed above

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
From January 2024 for five years
Access Criteria
On request

Locations