NCT02733523

Brief Summary

Motivations: Socio-economic and education determinants have a big impact on health outcomes, in terms of worse health status in populations living in more disadvantaged conditions. Social capital, self-management and health literacy are some of the intermediate determinants, with the potential to mitigate health inequalities through interventions driven by local health agents. These three determinants are intensely interlinked and have, separately, impacts on self-perceived health. Social capital is defined in this project as an umbrella concept, which includes quantitative aspects of social resources (structural social capital: social networks and contacts, social and civic participation) as well as qualitative or subjective aspects (cognitive social capital: perceived social support, feeling of belonging and trust) and covers relations between subjects at a micro or individual level (family and friends) as well as at a macro or community level. Health literacy is understood as cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. Both are key aspects for self-management behaviours. The target of our research project are older people living in urban socioeconomically disadvantaged areas, since ageing is in itself an inequality axis and urban environments concentrate the highest health disparities. Objectives: With the aim to reduce health inequality, an intervention has been designed to promote self-management, health literacy and social capital among older people who perceived their health as fair or poor and are living in urban socioeconomically disadvantaged areas with the aim of improving their self-perceived health. Secondarily, the efficacy of the intervention will be analysed in terms of increasing self-management, health literacy and social capital (social support and social participation), quality of life, mental health and healthy lifestyles. In third place, behavioural health patterns will be identified in relation to health literacy, social capital, gender, socioeconomic and educational level, and they will be linked to the intervention efficacy levels.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

February 10, 2016

Last Update Submit

February 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-perceived health

    Same question than the 12 items Short Form Survey from the RAND Medical Outcomes Study. Answers will be recategorized as positive perception (excellent, very good or good) vs negative (regular or bad)

    at 3 months (just after the intervention)

Secondary Outcomes (14)

  • Self-perceived health

    at month 3 (just after the intervention) and at month 12 (9 months after the intervention)

  • Health related quality of life

    at month 3 (just after the intervention) and at month 12 (9 months after the intervention)

  • Self-rated quality of life

    t month 3 (just after the intervention) and at month 12 (9 months after the intervention)

  • Loneliness

    t month 3 (just after the intervention) and at month 12 (9 months after the intervention)

  • Depressive symptoms

    at month 3 (just after the intervention) and at month 12 (9 months after the intervention)

  • +9 more secondary outcomes

Study Arms (2)

Program "Sentirnos bien"

EXPERIMENTAL

The intervention Program "Sentirnos bien" is based around a group dynamic, held once a week during 3 months, aimed at: 1. Promoting the uptake of self-care healthy habits 2. Promoting social capital at individual level: 3. Promoting health literacy

Behavioral: Program "Sentirnos bien" (Feeling well)

Control arm

NO INTERVENTION

The control arm will receive no intervention. Once the trial is finished, i.e. after the last follow-up evaluation, this arm will receive the intervention (waiting-list approach).

Interventions

Group-based intervention delivered face-to face and held once a week during 3 months. It comprises: 1. Promoting the uptake of self-care healthy habits: providing information, setting personal goals and sharing experiences to facilitate behavioural change, specially on physical activity and healthy dietary habits. 2. Promoting social capital at individual level: facilitating mutual knowledge and mutual support among participants and fostering participation in sociocultural and community activities in the neighbourhood through visits to the community assets accompanied by volunteers. 3. Promoting health literacy: improving navigation through the health care system, communication with health professionals, as well as the understanding and decision making when buying food.

Program "Sentirnos bien"

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • community-dwelling older adults living in the urban areas of Barcelona, Blanes or Reus in socio-economically disadvantaged neighbourhoods.
  • perception of their health as regular or bad according to the first question of the 12 items Short Form Survey from the RAND Medical Outcomes Study.

You may not qualify if:

  • dependency to go to the local primary care center
  • cognitive decline or dementia as diagnose
  • any health condition that contraindicates physical activity
  • terminal illness
  • severe mental health disorders that difficult participating in a group dynamic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.

    PMID: 21768583BACKGROUND
  • Foster G, Taylor SJ, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education programmes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005108. doi: 10.1002/14651858.CD005108.pub2.

    PMID: 17943839BACKGROUND
  • Fried LP, Carlson MC, Freedman M, Frick KD, Glass TA, Hill J, McGill S, Rebok GW, Seeman T, Tielsch J, Wasik BA, Zeger S. A social model for health promotion for an aging population: initial evidence on the Experience Corps model. J Urban Health. 2004 Mar;81(1):64-78. doi: 10.1093/jurban/jth094.

    PMID: 15047786BACKGROUND
  • Ahnquist J, Wamala SP, Lindstrom M. Social determinants of health--a question of social or economic capital? Interaction effects of socioeconomic factors on health outcomes. Soc Sci Med. 2012 Mar;74(6):930-9. doi: 10.1016/j.socscimed.2011.11.026. Epub 2012 Jan 21.

    PMID: 22305807BACKGROUND
  • Kawachi I, Kennedy BP, Glass R. Social capital and self-rated health: a contextual analysis. Am J Public Health. 1999 Aug;89(8):1187-93. doi: 10.2105/ajph.89.8.1187.

    PMID: 10432904BACKGROUND
  • Nyqvist F, Forsman AK, Giuntoli G, Cattan M. Social capital as a resource for mental well-being in older people: a systematic review. Aging Ment Health. 2013;17(4):394-410. doi: 10.1080/13607863.2012.742490. Epub 2012 Nov 27.

    PMID: 23186534BACKGROUND
  • Blancafort Alias S, Monteserin Nadal R, Moral I, Roque Figols M, Rojano I Luque X, Coll-Planas L. Promoting social capital, self-management and health literacy in older adults through a group-based intervention delivered in low-income urban areas: results of the randomized trial AEQUALIS. BMC Public Health. 2021 Jan 7;21(1):84. doi: 10.1186/s12889-020-10094-9.

  • Coll-Planas L, Blancafort S, Rojano X, Roque M, Monteserin R. Promoting self-management, health literacy and social capital to reduce health inequalities in older adults living in urban disadvantaged areas: protocol of the randomised controlled trial AEQUALIS. BMC Public Health. 2018 Mar 13;18(1):345. doi: 10.1186/s12889-018-5219-x.

Study Officials

  • Laura Coll-Planas, MD

    Fundació Salut i Envelliment UAB

    PRINCIPAL INVESTIGATOR
  • Sergi Blancafort, PhD

    Fundació Salut i Envelliment UAB

    PRINCIPAL INVESTIGATOR
  • Rosa Monteserin, MD PhD

    Equipo Atencio Primaria Sardenya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, head of research on health and ageing

Study Record Dates

First Submitted

February 10, 2016

First Posted

April 11, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2017

Last Updated

February 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share