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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02733523
Other study ID # FSIE-Recercaixa2014
Secondary ID
Status Completed
Phase N/A
First received February 10, 2016
Last updated February 6, 2018
Start date January 2016

Study information

Verified date February 2018
Source Fundacio Salut i Envelliment UAB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 390
Est. completion date
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Intervention

Behavioral:
Program "Sentirnos bien" (Feeling well)
Group-based intervention delivered face-to face and held once a week during 3 months. It comprises: 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. 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. 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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Fundacio Salut i Envelliment UAB Equip Atencio Primaria Sardenya, Recercaixa

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Self-perceived health Thermometer from 0-100 at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Health related quality of life 12 items Short Form Survey from the RAND Medical Outcomes Study. at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Self-rated quality of life Thermometer from 0-100 t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Loneliness Scale Gierveld and De Jong t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Depressive symptoms Geriatric Depression Scale at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Physical activity International Physical Activity Questionnaire (IPAQ) at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Short Physical Performance Battery Functional test that scores performance in three physical aspects: balance, strength and gait speed. at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Health service use Times attending primary and hospital health care at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Unintended effects Questions ad hoc to assess effects not intended by the intervention perceived negatively by the participant. at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Self-care / healthy habits Scale ASA (Appraisal of Self-Care Agency Scale) at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Health literacy questions from the European Health Literacy Scale (HLS EU-16) at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Social capital 2 questions from the European Values Survey at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Social support Questionnaire "Inventario de recursos sociales en ancianos" from Díaz Veiga at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Secondary Social participation Questionnaire "Escala Este II de Soledad - Índice de participación social subjetiva" at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
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