Quality of LifeNCT07720752
Impact of a Climate-Adapted Self-Management Intervention for Hypertension: A Randomized Controlled Trial Examining Psychosocial and Environmental Determinants
A study testing Climate-Adapted Self-Management Intervention in people with Quality of Life and Psychological Distress, run by Fatima Jinnah Women University at 3 sites in Pakistan.
Trial summary
This study aims to evaluate the effectiveness of a Climate-Adapted Self-Management Intervention in improving the quality of life among adults with hypertension. The study employed a two-phase design comprising a cross-sectional survey followed by a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Quality of Life, Psychological Distress, Climate Change Anxiety
- What is being tested?
- Climate-Adapted Self-Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesPakistan
- Study dates
- 1 Feb 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 25-65 years.
- Clinically diagnosed with primary hypertension by a medical professional.
- Receiving antihypertensive medication for at least one year.
- Able to read and understand English.
- Access to internet services for participation in online intervention sessions.
- Willing and able to provide written informed consent.
Who cannot join
- Severe chronic physical illness (e.g., neurological disorders, cancer, severe cardiac conditions, stroke, diabetes, or other chronic diseases besides hypertension).
- Chronic psychological illness.
- Pregnancy.
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Capital Hospital Islamabad
Islamabad, Islamabad, 46000
Fauji Foundation Hospital
Rawalpindi, Punjab Province, 45000
Cantonment Board General Hospital Rawalpindi
Rawalpindi, Punjab Province, 46000
About this study
This study aims to evaluate the effectiveness of a Climate-Adapted Self-Management Intervention in improving the quality of life among adults with hypertension. The study employed a two-phase design comprising a cross-sectional survey followed by a randomized controlled trial. The intervention was evaluated for its effects on quality of life, psychological distress, health behaviors, environmental determinants, and blood pressure.
Read the detailed description
The study was conducted in two phases. Phase I consisted of a cross-sectional survey that examined psychosocial factors, health behaviors, environmental determinants, and quality of life among adults with hypertension. Participants were recruited from public and private hospitals in Rawalpindi and Islamabad using convenience purposive sampling.
Phase II consisted of a two-arm, parallel-group randomized controlled trial. Eligible participants identified during Phase I were randomly assigned to either the experimental group or the wait-list control group. The experimental group received the Climate-Adapted Self-Management Intervention in addition to usual medical care, whereas the wait-list control group received usual medical care together with generic health information during the study period. The intervention comprised six structured sessions delivered over 6 weeks, with one session per week lasting approximately 40-45 minutes. The sessions included self-management education, healthy lifestyle promotion, stress management, mindfulness, climate change awareness, heatwave preparedness, and behavioral coping strategies.
The Climate-Adapted Self-Management Intervention was adapted from the Chronic Disease Self-Management Program (CDSMP) of the Self-Management Resource Center (SMRC), USA, with permission. The principal investigator completed SMRC training before implementing the intervention.
Outcome assessments were conducted at baseline and immediately after completion of the intervention. The primary outcome was quality of life, while secondary outcomes included psychological distress, health behaviors, climate change anxiety, heatwave-related knowledge, awareness, practices and behaviors, and blood pressure. The effectiveness of the Climate-Adapted Self-Management Intervention was evaluated by comparing post-intervention outcomes between the experimental and wait-list control groups. After completion of the post-intervention assessment, the Climate-Adapted Self-Management Intervention was also offered to participants in the wait-list control group to ensure equitable access to the intervention.
- Conditions
- Quality of Life, Psychological Distress, Climate Change Anxiety, Health Behaviors, Heatwave Knowledge, Awareness, Practices, and Behaviors
- Being tested
- Climate-Adapted Self-Management Intervention
- Medical subject headings
- Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Climate-Adapted Self-Management InterventionBehavioural
The Climate-Adapted Self-Management Intervention is a behavioral intervention developed for adults with hypertension. It integrates evidence-based self-management strategies with climate-related health education. The intervention is delivered in six sessions, one session per week, with each session lasting approximately 40-45 minutes. Sessions include psychoeducation, self-management skills, healthy lifestyle promotion, medication adherence, stress management, mindfulness, climate change awareness, heatwave preparedness, behavioral coping strategies, goal setting, and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Who receives the intervention, i.e., Climate-Adapted Self-Management Intervention Receives: Behavioral: Climate-Adapted Self-Management Intervention |
| Waitlist Control | Active comparator | Who receives usual medical care, along with generic health information, throughout the study period and receive the Climate-Adapted Self-Management Intervention once the study is completed. Receives: Behavioral: Climate-Adapted Self-Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Scale Urdu Version
It is a 26-item instrument that measures four domains: physical health, psychological health, social relationships, and environmental health. A total score was calculated by summing the responses to all 26 items, with a possible score range of 26 to 130. Higher scores indicate better quality of life, whereas lower scores indicate poorer quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Feb 2026
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Sohail, Fatima Jinnah Women University
- Investigators
- Ayesha Sohail, Mphil Scholar, Principal investigator, Fatima Jinnah women University, Rawalpindi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720752
- Sponsor's protocol ID
- FJWU/EC/2026/145
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Climate-Adapted Self-Management Intervention for Hypertension: A Randomized Controlled Trial Examining Psychosocial and Environmental Determinants
- ClinicalTrials.gov ID
- NCT07720752
- Acronym / sponsor ID
- FJWU/EC/2026/145
- Conditions
- Quality of Life, Psychological Distress, Climate Change Anxiety, Health Behaviors, Heatwave Knowledge, Awareness, Practices, and Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of a Climate-Adapted Self-Management Intervention in improving the quality of life among adults with hypertension. The study employed a two-phase design comprising a cross-sectional survey followed by a randomized controlled trial. The intervention was evaluated for its effects on quality of life, psychological distress, health behaviors, environmental determinants, and blood pressure.
Detailed description
The study was conducted in two phases. Phase I consisted of a cross-sectional survey that examined psychosocial factors, health behaviors, environmental determinants, and quality of life among adults with hypertension. Participants were recruited from public and private hospitals in Rawalpindi and Islamabad using convenience purposive sampling.
Phase II consisted of a two-arm, parallel-group randomized controlled trial. Eligible participants identified during Phase I were randomly assigned to either the experimental group or the wait-list control group. The experimental group received the Climate-Adapted Self-Management Intervention in addition to usual medical care, whereas the wait-list control group received usual medical care together with generic health information during the study period. The intervention comprised six structured sessions delivered over 6 weeks, with one session per week lasting approximately 40-45 minutes. The sessions included self-management education, healthy lifestyle promotion, stress management, mindfulness, climate change awareness, heatwave preparedness, and behavioral coping strategies.
The Climate-Adapted Self-Management Intervention was adapted from the Chronic Disease Self-Management Program (CDSMP) of the Self-Management Resource Center (SMRC), USA, with permission. The principal investigator completed SMRC training before implementing the intervention.
Outcome assessments were conducted at baseline and immediately after completion of the intervention. The primary outcome was quality of life, while secondary outcomes included psychological distress, health behaviors, climate change anxiety, heatwave-related knowledge, awareness, practices and behaviors, and blood pressure. The effectiveness of the Climate-Adapted Self-Management Intervention was evaluated by comparing post-intervention outcomes between the experimental and wait-list control groups. After completion of the post-intervention assessment, the Climate-Adapted Self-Management Intervention was also offered to participants in the wait-list control group to ensure equitable access to the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Climate-Adapted Self-Management InterventionWho receives the intervention, i.e., Climate-Adapted Self-Management Intervention |
| Waitlist Control | Active comparator | Behavioral: Climate-Adapted Self-Management InterventionWho receives usual medical care, along with generic health information, throughout the study period and receive the Climate-Adapted Self-Management Intervention once the study is completed. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 25-65 years.
- Clinically diagnosed with primary hypertension by a medical professional.
- Receiving antihypertensive medication for at least one year.
- Able to read and understand English.
- Access to internet services for participation in online intervention sessions.
Key exclusion criteria (3 listed)
- Severe chronic physical illness (e.g., neurological disorders, cancer, severe cardiac conditions, stroke, diabetes, or other chronic diseases besides hypertension).
- Chronic psychological illness.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Climate-Adapted Self-Management InterventionThe Climate-Adapted Self-Management Intervention is a behavioral intervention developed for adults with hypertension. It integrates evidence-based self-management strategies with climate-related health education. The intervention is delivered in six sessions, one session per week, with each session lasting approximately 40-45 minutes. Sessions include psychoeducation, self-management skills, healthy lifestyle promotion, medication adherence, stress management, mindfulness, climate change awareness, heatwave preparedness, behavioral coping strategies, goal setting, and relapse prevention. | Behavioural | Experimental, Waitlist Control |
Primary outcome
World Health Organization Quality of Life Scale Urdu Version
Time frame: 3 months
It is a 26-item instrument that measures four domains: physical health, psychological health, social relationships, and environmental health. A total score was calculated by summing the responses to all 26 items, with a possible score range of 26 to 130. Higher scores indicate better quality of life, whereas lower scores indicate poorer quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Sohail, Mphil Scholar principal investigator
Fatima Jinnah women University, Rawalpindi, Pakistan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Climate-Adapted Self-Management Intervention in people with Quality of Life and Psychological Distress, run by Fatima Jinnah Women University at 3 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life Scale Urdu Version (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.