Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 11:40 PM
Study NCT ID:
NCT04659694
Status:
WITHDRAWN
Last Update Posted:
2020-12-09
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Intervention on Health in Older Care Home Residents
Sponsor:
Bournemouth University
Organization:
Study Overview
Official Title:
The Physical and Psychosocial Effects of a Whole Systems Wellness Intervention for Older Adults Living in Care Homes: A Feasibility Study
Status:
WITHDRAWN
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawal of PhD
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
1. Measuring hand grip strength by having to grip a device as firmly as possible and measurements will be taken,
2. Answering questionnaires about quality of life, daily routine, appetite, thoughts about wellness activities the participants have participated in,
3. 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.
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:
1. Measuring hand grip strength by having to grip a device as firmly as possible and measurements will be taken,
2. Answering questionnaires about quality of life, daily routine, appetite, thoughts about wellness activities the participants have participated in,
3. 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:
1. 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.
2. 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.
3. 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:
4. There will be no conflict of interest in the study.
1. 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.
2. 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.
3. 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:
4. There will be no conflict of interest in the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: