- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02733523
Self-management, Health Literacy and Social Capital in Socioeconomically Disadvantaged Older Adults (AEQUALIS)
Promoting Self-Management, Health Literacy And Social Capital In Socioeconomically Disadvantaged Older Adults To Reduce Later Life Health Inequalities: A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Program "Sentirnos bien"
The intervention Program "Sentirnos bien" is based around a group dynamic, held once a week during 3 months, aimed at:
|
Group-based intervention delivered face-to face and held once a week during 3 months. It comprises:
|
|
NO_INTERVENTION: Control arm
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-perceived health
Time Frame: at 3 months (just after the intervention)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-perceived health
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
Thermometer from 0-100
|
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
|
Health related quality of life
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
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)
|
|
Self-rated quality of life
Time Frame: t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
Thermometer from 0-100
|
t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
|
Loneliness
Time Frame: t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
Scale Gierveld and De Jong
|
t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
|
Depressive symptoms
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
Geriatric Depression Scale
|
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
|
Physical activity
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
International Physical Activity Questionnaire (IPAQ)
|
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
|
Short Physical Performance Battery
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
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)
|
|
Health service use
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
Times attending primary and hospital health care
|
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
|
Unintended effects
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
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)
|
|
Self-care / healthy habits
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
Scale ASA (Appraisal of Self-Care Agency Scale)
|
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
|
Health literacy
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
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)
|
|
Social capital
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
2 questions from the European Values Survey
|
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
|
Social support
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
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)
|
|
Social participation
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura Coll-Planas, MD, Fundacio Salut i Envelliment UAB
- Principal Investigator: Sergi Blancafort, PhD, Fundacio Salut i Envelliment UAB
- Principal Investigator: Rosa Monteserin, MD PhD, Equipo Atencio Primaria Sardenya
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FSIE-Recercaixa2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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