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Effect of an Intervention on Health in Older Care Home Residents

Primary Purpose

Sedentary Behavior, Frail Elderly Syndrome, Frailty

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wellness programme provided by Oomph! Wellness company
Sponsored by
Bournemouth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sedentary Behavior focused on measuring elderly, older adults, physical activity, psychosocial activity, care home, care home staff, care home residents

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (care home residents):

  • Residents' Age: 65 years of age and older living in a care home, and
  • Have no cognitive impairment or in case of cognitive impairment have a score of more than 14 on the Montreal Cognitive Assessment (MOCA) screening (Nasreddine et al 2005) and who are able to provide consent or have next-of-kin/relatives/ friends who can give consent on their behalf.

Inclusion criteria (care home employee):

• All full time care home employees and part-time employees who work in the care home on a long-term basis and interact with the care home residents

Exclusion criteria (care home residents):

  • 65 years of age and above residents who score less than 14 on the MOCA screening will have moderate to severe cognitive impairment as they may not be able to follow the intervention and tests, or
  • with physical or neurological condition that impedes the usage of the hand grip dynamometer, or
  • with skin contraindications to wearing an accelerometer, or
  • Known to have a diagnosis of severe dementia or other health conditions that contraindicate their participation in the study, or
  • residents with cognitive impairment where English is not primary language as screening test is language sensitive, or
  • residents who are registered blind with or without mild cognitive impairment

Exclusion criteria (care home employees):

• Part time employees who work on an ad hoc basis and only have intermittent/minimal interaction with care home residents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Single arm study

    Arm Description

    This study only contains one arm

    Outcomes

    Primary Outcome Measures

    Accelerometer(Actigraph)
    To measure the level of physical activity
    Accelerometer(Actigraph)
    To measure the level of physical activity
    Accelerometer(Actigraph)
    To measure the level of physical activity
    Barthel Index
    To measure the independence in performing activities of daily living
    Barthel Index
    To measure the independence in performing activities of daily living
    Barthel Index
    To measure the independence in performing activities of daily living
    Hand grip dynamometer
    To measure their grip strength by using their hands to grip the dynamometer
    Hand grip dynamometer
    To measure their grip strength by using their hands to grip the dynamometer
    Hand grip dynamometer
    To measure their grip strength by using their hands to grip the dynamometer
    Simplified Nutritional Appetite Questionnaire (SNAQ)
    Self-administered questionnaire that will measure appetite levels
    Simplified Nutritional Appetite Questionnaire (SNAQ)
    Self-administered questionnaire that will measure appetite levels
    Simplified Nutritional Appetite Questionnaire (SNAQ)
    Self-administered questionnaire that will measure appetite levels
    EQ-5D-5L questionnaire
    self-administered questionnaire that will measure quality of life
    EQ-5D-5L questionnaire
    self-administered questionnaire that will measure quality of life
    EQ-5D-5L questionnaire
    self-administered questionnaire that will measure quality of life
    Focus group discussion for care home staff
    this will be a guided discussion facilitated by the researcher to understand the feasibility of implementing personalised interactive exercises & activities in a care home

    Secondary Outcome Measures

    Full Information

    First Posted
    May 21, 2020
    Last Updated
    December 2, 2020
    Sponsor
    Bournemouth University
    Collaborators
    Oomph! Wellness, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Solent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04659694
    Brief Title
    Effect of an Intervention on Health in Older Care Home Residents
    Official Title
    The Physical and Psychosocial Effects of a Whole Systems Wellness Intervention for Older Adults Living in Care Homes: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawal of PhD
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bournemouth University
    Collaborators
    Oomph! Wellness, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Solent University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Care home residents spent 79% of their time being sedentary. Reduced physical activity and lack of mental stimulation causes general weakness and frailty in older adults that can result in increased healthcare needs. It is important that care home residents spend their time being both physically and psychosocially engaged. This study aims to investigate the effect of a wellness programme on physical and psychosocial wellbeing in older adults living in care homes. Through this process this study will assess the feasibility of implementing the programme and collecting data in care home settings. There are two main groups of participants, 1) care home residents and 2) care home staff. Care home residents will have data collected at three time points. The first time point will be before the intervention (baseline) in the care home setting. The second time point will be three months after the intervention has been delivered. The third time point will be 6 months after the intervention has been delivered. The following measurements will be conducted: Measuring hand grip strength by having to grip a device as firmly as possible and measurements will be taken, Answering questionnaires about quality of life, daily routine, appetite, thoughts about wellness activities the participants have participated in, Wearing a little 'match box-like' device (that measures daily movements and sleep patterns) for 7 consecutive days. Care home staff will be invited to participate in a focus group discussion 6 months after the intervention. Hence, this research will aim to understand the impact of a wellness programme that incorporates physical and psychosocial components that targets the holistic wellbeing of older adults.
    Detailed Description
    The following potential issues have been identified: This feasibility study is being carried out in older adults living in care homes. Older adults are considered to be vulnerable population by the definition of the World Health Organisation. This study involves residents with cognitive impairment who may not be able to give consent for themselves to take part in the study. To overcome these issues, the research team is very mindful not to exclude residents with cognitive impairment who otherwise are able to participate in the Wellness activities. Th investigators will strictly adopt the Dewing process of gaining consent for older adults with cognitive impairment which involves ongoing consent monitoring. The investigators have followed the guidelines of Mental Capacity Act 2005 and designed participant information sheets and consulted declaration form who could consent on the participant's behalf (consultee). If consent is not obtained, the participant will not be recruited into the study. The consultee will be able to withdraw consent at any time in the study. Any visible distress observed during participation (eg. use of handgrip dynamometer & accelerometer) will be recorded and the participant will be withdrawn from the study. Participants will also be regularly reminded that they can choose to withdraw from the study at any point, without any explanation and that care received would not be affected or compromised due to this study. All data collected will be stored on password protected computers and/or the BU secure server and will be handled in accordance with the General Data Protection Regulation 2018 and Data Protection Act 2018. Data will only be accessed by the investigator and the supervisor, and the participant's identity will be anonymised using a coding system. Conflict of Interest: There will be no conflict of interest in the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sedentary Behavior, Frail Elderly Syndrome, Frailty, Lifestyle, Sedentary, Life Style Induced Illness
    Keywords
    elderly, older adults, physical activity, psychosocial activity, care home, care home staff, care home residents

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A mixed method design is an integrative methodology in understanding the social inquiry into the implementation of an intervention(Greene,2008). The whole system wellness intervention will be applied to care home residents by (intervention-trained) care home staff.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm study
    Arm Type
    Other
    Arm Description
    This study only contains one arm
    Intervention Type
    Other
    Intervention Name(s)
    Wellness programme provided by Oomph! Wellness company
    Other Intervention Name(s)
    Oomph! Wellness
    Intervention Description
    The Oomph! wellness programme empowers older adults to lead a full life for life. It focuses on building an individual-centred programme that consists of a varied exercise and activity plans including days out. All of these, aims in improving the physical and psychosocial wellness in older adults. This intervention is a three day training session for care home staff to understand and learn how to facilitate care activities within their care home.
    Primary Outcome Measure Information:
    Title
    Accelerometer(Actigraph)
    Description
    To measure the level of physical activity
    Time Frame
    Pre-intervention for 7 days
    Title
    Accelerometer(Actigraph)
    Description
    To measure the level of physical activity
    Time Frame
    3 months post-intervention
    Title
    Accelerometer(Actigraph)
    Description
    To measure the level of physical activity
    Time Frame
    6 months post-intervention
    Title
    Barthel Index
    Description
    To measure the independence in performing activities of daily living
    Time Frame
    Pre-intervention
    Title
    Barthel Index
    Description
    To measure the independence in performing activities of daily living
    Time Frame
    3 months post-intervention
    Title
    Barthel Index
    Description
    To measure the independence in performing activities of daily living
    Time Frame
    6 months post-intervention
    Title
    Hand grip dynamometer
    Description
    To measure their grip strength by using their hands to grip the dynamometer
    Time Frame
    Pre-intervention
    Title
    Hand grip dynamometer
    Description
    To measure their grip strength by using their hands to grip the dynamometer
    Time Frame
    3 months post-intervention
    Title
    Hand grip dynamometer
    Description
    To measure their grip strength by using their hands to grip the dynamometer
    Time Frame
    6 months post-intervention
    Title
    Simplified Nutritional Appetite Questionnaire (SNAQ)
    Description
    Self-administered questionnaire that will measure appetite levels
    Time Frame
    Completed pre-intervention
    Title
    Simplified Nutritional Appetite Questionnaire (SNAQ)
    Description
    Self-administered questionnaire that will measure appetite levels
    Time Frame
    Completed 3 months post-intervention and 6 months post intervention
    Title
    Simplified Nutritional Appetite Questionnaire (SNAQ)
    Description
    Self-administered questionnaire that will measure appetite levels
    Time Frame
    Completed 6 months post-intervention
    Title
    EQ-5D-5L questionnaire
    Description
    self-administered questionnaire that will measure quality of life
    Time Frame
    Completed pre-intervention
    Title
    EQ-5D-5L questionnaire
    Description
    self-administered questionnaire that will measure quality of life
    Time Frame
    Completed 3 months post-intervention and 6 months post intervention
    Title
    EQ-5D-5L questionnaire
    Description
    self-administered questionnaire that will measure quality of life
    Time Frame
    Completed 6 months post-intervention
    Title
    Focus group discussion for care home staff
    Description
    this will be a guided discussion facilitated by the researcher to understand the feasibility of implementing personalised interactive exercises & activities in a care home
    Time Frame
    Conducted at the 6 month timeline of data collection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria (care home residents): Residents' Age: 65 years of age and older living in a care home, and Have no cognitive impairment or in case of cognitive impairment have a score of more than 14 on the Montreal Cognitive Assessment (MOCA) screening (Nasreddine et al 2005) and who are able to provide consent or have next-of-kin/relatives/ friends who can give consent on their behalf. Inclusion criteria (care home employee): • All full time care home employees and part-time employees who work in the care home on a long-term basis and interact with the care home residents Exclusion criteria (care home residents): 65 years of age and above residents who score less than 14 on the MOCA screening will have moderate to severe cognitive impairment as they may not be able to follow the intervention and tests, or with physical or neurological condition that impedes the usage of the hand grip dynamometer, or with skin contraindications to wearing an accelerometer, or Known to have a diagnosis of severe dementia or other health conditions that contraindicate their participation in the study, or residents with cognitive impairment where English is not primary language as screening test is language sensitive, or residents who are registered blind with or without mild cognitive impairment Exclusion criteria (care home employees): • Part time employees who work on an ad hoc basis and only have intermittent/minimal interaction with care home residents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jane Murphy
    Organizational Affiliation
    Professor of Nutrition
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data are strictly confidential and will not be accessed by researcher. This will be assessed by care home staff.
    Citations:
    PubMed Identifier
    22678747
    Citation
    Bradshaw SA, Playford ED, Riazi A. Living well in care homes: a systematic review of qualitative studies. Age Ageing. 2012 Jul;41(4):429-40. doi: 10.1093/ageing/afs069. Epub 2012 Jun 7.
    Results Reference
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    Effect of an Intervention on Health in Older Care Home Residents

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