Neighbourhood active & connected: an integral approach to healthy ageing
| ISRCTN | ISRCTN17170098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17170098 |
| Secondary identifying numbers | 50-55510-98-013 |
- Submission date
- 11/10/2022
- Registration date
- 17/10/2022
- Last edited
- 06/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The rapid and double ageing of our global society requires serious attention, as it negatively impacts older adults, their (in)formal caregivers and society as a whole. Significant negative consequences of global ageing are the rising prevalence of chronic diseases and older adults' dependency on care, the substantial decline in physical activity and social connectedness, and the corresponding increase in loneliness. While these problems affect most older adults, those with low socioeconomic status are most vulnerable. The World Health Organisation endorsed this problematic situation. It declared healthy ageing as a major focal point to prevent and decrease ageing-related problems and focus on older adults' strengths and possibilities.
Healthy ageing is multidimensional. It is influenced by socioeconomic, cultural and environmental conditions in which individuals, social networks and organisations are situated. Additionally, it is affected by the personal behaviour of individuals. Given this complexity, an integral approach seems essential and promising to influence this broad range of factors adequately.
This study aims to evaluate the effectiveness of Neighbourhood Active & Connected (NAC): a neighbourhood-oriented integral approach to promote healthy ageing in community-dwelling older adults, focusing on those with a low SES. This evaluation will demonstrate whether an integral approach like NAC, which considers environmental factors and relies on the collaborative effort of the neighbourhood, is successful in improving the health and well-being of older adults with a low SES.
Who can participate?
Older adults aged 65 years and over living in the Dutch municipalities of Bergeijk, Bladel, Eindhoven, Heerlen, and Voerendaal.
What does the study involve?
NAC will be tested in an RCT executed in 10 to 15 neighbourhoods within the abovementioned municipalities. Neighbourhoods will be randomly assigned to the experimental or control group. Both groups will simultaneously complete questionnaires at baseline, after 3 and 6 months. The experimental group receives NAC at the start of the RCT, while the control group is offered an exercise intervention (Active Plus, part of NAC) after six months. The questionnaires are an amalgamation of several existing and validated surveys, such as the SQUASH, De Jong Gierveld 6-items Loneliness Scale, and the EQ5D.
What are the possible benefits and risks of participating?
NAC will target multiple ageing-related risk factors, facilitate processes and systems in community care surrounding older adults, and aid local stakeholders in reaching a holistic and integral viewpoint. Local stakeholders will consistently treat root causes of (health) problems by activating and coaching older adults whilst being sensitive to their daily realities. There are no risks associated with participating in the intervention for older adults.
Where is the study run from?
The study is conducted by the Department of Health Psychology at the Open Universiteit in Heerlen (the Netherlands). Participants will be recruited in close collaboration with the involved Dutch municipalities.
When is the study starting, and how long is it expected to run for?
October 2022 to January 2024
Who is funding the study?
The study is funded by the Netherlands Organisation for Health Research and Development (ZonMw, project no. 50-55510-98-013). The study protocol was reviewed and approved by ZonMw.
Who is the main contact?
Lieke J.E. Duijsens, lieke.duijsens@ou.nl
Contact information
Principal Investigator
Valkenburgerweg 177
Heerlen
6419 AT
Netherlands
 ORCID ID |
0000-0001-9209-6449 |
|---|---|
| Phone | +31 455762626 |
| catherine.bolman@ou.nl |
Scientific
Valkenburgerweg 177
Heerlen
6419 AT
Netherlands
| ORCID ID |
0000-0003-3923-0922 |
|---|---|
| Phone | +31 653437241 |
| lieke.duijsens@ou.nl |
Study information
| Study design | Interventional blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Healthy ageing in older adults with a low socio-economic position: effectiveness of an integral neighbourhood-oriented approach |
| Study objectives | H1: After participating in Neighbourhood Active & Connected, older adults spend more minutes per week on moderate to vigorous physical activity than before. H2: Older adults who participated in Neighbourhood Active & Connected report less loneliness than they previously did. H3: After participating in Neighbourhood Active & Connected, older adults experience improved social cohesion in their community. H4: Neighbourhood Active & Connected participants use digital media and the internet more frequently following the intervention. H5: Older adults who participated in Neighbourhood Active & Connected experience a better quality of life than their matched peers who did not participate. H6: After participating in Neighbourhood Active & Connected, older adults use local activities and support services more. |
| Ethics approval(s) | Approved 28/11/2022, central ethical review committee of the Open University of the Netherlands (Valkenburgerweg 177, 6419 AT Heerlen, Netherlands; ceto@ou.nl), ref: U202209546 |
| Health condition(s) or problem(s) studied | Encouraging healthy ageing in older adults (aged 65 and over) with a low socio-economic status. |
| Intervention | Neighbourhood Active & Connected (NAC) will be tested in 10 to 15 (deprived) neighbourhoods spread across five Dutch municipalities. Within each municipality, each participating neighbourhood will be randomly assigned to the experimental group or a waiting list control group by generating random numbers (0 = Control; 1 = Intervention) in Microsoft Excel. The experimental group receives NAC: a neighbourhood-oriented integral approach to encourage healthy ageing in community-dwelling older adults. We developed NAC last year in consultation with older adults and local stakeholders (i.e. co-creation). The final approach consists of several components: 1) the computer-tailored and proven-effective exercise intervention Active Plus, 2) a booklet with activities and support services in the local neighbourhood, 3) a stamp card that allows older adults to discover local initiatives for free, and 4) a neighbourhood network of stakeholders working together from a shared perspective on healthy ageing. The neighbourhood network informs older adults about local activities and support services, and motivates older adults to visit these initiatives. The total NAC intervention lasts approximately three months. To test NAC's (short- and long-term) effectiveness, participants fill in a questionnaire at baseline, after 3 and 6 months. The waiting list control group answers the same questionnaires simultaneously and receives the Active Plus physical activity intervention after six months. |
| Intervention type | Behavioural |
| Primary outcome measure | At baseline, after 3 and 6 months: 1. Physical activity assessed with the Short Questionnaire to Assess Heatlh Enhancing Physical Activity (SQUASH). 2. Loneliness assessed by the 6-item De Jong Gierveld Loneliness scale. 3. Social cohesion assessed by the 6-item scale of the Dutch CBS Veiligheidsmonitor (Safety-monitor). 4. Quality of life measured with the EQ5D questionnaire. |
| Secondary outcome measures | Digital activity and literacy will be assessed by a shortened version of the Dutch CBS questionnaire on internet use and digital skills at baseline, after 3 and 6 months |
| Overall study start date | 12/10/2022 |
| Completion date | 01/01/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 868 |
| Key inclusion criteria | 1. Participants have to be 65 years or older. 2. Participants have to live independently. (For potential participants living in sheltered housing or group facilities, the situation will be assessed per participant; refer to exclusion criteria). |
| Key exclusion criteria | 1. Having cognitive impairments or disabilities 2. Being unable to leave home independently. 3. Being unable to use public facilities in the neighbourhood independently. 4. Lack of proficiency in the Dutch language (given the intervention material is provided in Dutch). |
| Date of first enrolment | 01/01/2023 |
| Date of final enrolment | 11/05/2023 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Heerlen
6419 AT
Netherlands
Sponsor information
Government
Laan van Nieuw Oost-Indië 334
The Hague (Den Haag)
2593 CE
Netherlands
| Phone | +31 0703495111 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl/en/ |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | - Several planned open-access publications in peer-reviewed journals - Presenting results at international conferences and websites - An implementation guideline for municipalities that intend to implement EAC will be established |
| IPD sharing plan | Our products (data, intervention, implementation guideline) will be made available as online source material at the end of our study. The intervention products will be made available through the main project website, while all research data will be stored and made available through DANS Easy. Of course, we are following all ethical and legal regulations, such as the General Data Protection Regulation (GDPR/AVG). |
Editorial Notes
06/12/2024: The public title, study hypothesis, interventions and plain English summary were all updated to change the name of the intervention from 'Elderly active & connected' to 'Neighbourhood active & connected'.
05/12/2023: The following changes were made to the study record:
1. Ethics approval details and total final enrolment added.
2. The overall study end date was changed from 01/12/2023 to 01/01/2024.
3. The intention to publish date was changed from 01/02/2025 to 01/03/2025.
13/04/2023: The recruitment end date has been changed from 30/04/2023 to 11/05/2023.
04/01/2023: The ethics approval has been added.
17/10/2022: Trial's existence confirmed by ZonMw.
