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Withdrawn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
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
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
NCT ID
NCT04659694
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
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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