Effect of an Intervention on Health in Older Care Home Residents

NCT04659694 | Withdrawn

• 1 other identifier: 276089
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 1.Measuring hand grip strength by having to grip a device as firmly as possible and measurements will be taken,
2. 2.Answering questionnaires about quality of life, daily routine, appetite, thoughts about wellness activities the participants have participated in,
3. 3.Wearing a little 'match box-like' device (that measures daily movements and sleep patterns) for 7 consecutive days.

Conditions

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

Outcome Measures

Primary Outcomes (16)

• Accelerometer(Actigraph)

  To measure the level of physical activity

  Pre-intervention for 7 days

• Accelerometer(Actigraph)

  To measure the level of physical activity

  3 months post-intervention

• Accelerometer(Actigraph)

  To measure the level of physical activity

  6 months post-intervention

• Barthel Index

  To measure the independence in performing activities of daily living

  Pre-intervention

• Barthel Index

  To measure the independence in performing activities of daily living

  3 months post-intervention

• Barthel Index

  To measure the independence in performing activities of daily living

  6 months post-intervention

• Hand grip dynamometer

  To measure their grip strength by using their hands to grip the dynamometer

  Pre-intervention

• Hand grip dynamometer

  To measure their grip strength by using their hands to grip the dynamometer

  3 months post-intervention

• Hand grip dynamometer

  To measure their grip strength by using their hands to grip the dynamometer

  6 months post-intervention

• Simplified Nutritional Appetite Questionnaire (SNAQ)

  Self-administered questionnaire that will measure appetite levels

  Completed pre-intervention

• Simplified Nutritional Appetite Questionnaire (SNAQ)

  Self-administered questionnaire that will measure appetite levels

  Completed 3 months post-intervention and 6 months post intervention

• Simplified Nutritional Appetite Questionnaire (SNAQ)

  Self-administered questionnaire that will measure appetite levels

  Completed 6 months post-intervention

• EQ-5D-5L questionnaire

  self-administered questionnaire that will measure quality of life

  Completed pre-intervention

• EQ-5D-5L questionnaire

  self-administered questionnaire that will measure quality of life

  Completed 3 months post-intervention and 6 months post intervention

• EQ-5D-5L questionnaire

  self-administered questionnaire that will measure quality of life

  Completed 6 months post-intervention

• 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

  Conducted at the 6 month timeline of data collection

Study Arms (1)

Single arm study

OTHER

This study only contains one arm

Other: Wellness programme provided by Oomph! Wellness company

Interventions

Wellness programme provided by Oomph! Wellness company OTHER

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.

Also known as: Oomph! Wellness

Single arm study

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bournemouth University: lead
• Oomph! Wellness: collaborator
• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust: collaborator
• Solent University: collaborator

Related Publications (1)

• 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.

  PMID: 22678747 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane Murphy

  Professor of Nutrition

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: December 9, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2022
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share